Overview
The purpose of this post-marketing clinical use database surveillance is to observe the frequency, type, and degree of adverse device effects and adverse events in order to assure the safety of the medical device, and to collect safety and efficacy information for evaluating the results of its clinical use.
Description
The Surveillance will be conducted per the standards required by the Ministry of Health, Labour and Welfare (MHLW) and in the standards for post-marketing surveillances and studies [except for those defined in the Ministerial Ordinance on Good Clinical Practice for Medical Devices (MHLW Ordinance No. 36, 2005)] based on Paragraph 4, Article 23-2-9 (including application mutatis mutandis per Article 23-2-19 of Revised PAL) of the Law on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices, etc. (Law No. 145, 1960, hereinafter referred to as "Revised PAL") by the Marketing Authorization Holder or accredited foreign manufacturer of a medical device defined in Paragraph 1, Article 23-2-5 of Revised PAL.
Eligibility
Inclusion Criteria:
The device is used to percutaneously close the PDA of a patient who meets all of the
following:
- PDA ≤4 mm in diameter
- PDA ≥3 mm in length
- Weight ≥700 g
Exclusion Criteria:
- Age <3 days
- Coarctation of the aorta
- Left pulmonary artery stenosis
- Cardiac output that is dependent on right to left shunt through the PDA due to
pulmonary hypertension
- Thrombus in the implant site, or sign of venous thrombus in a vessel in which the
occluder is inserted and delivered
- Endocarditis, or infection that can cause bacteremia
- Allergic or potentially allergic to nickel
