MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER MUSCULAR VSD OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Complete Heart Block (2627)

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

The article, "transcatheter device closure of ventricular septal defects in children: a retrospective study at a single cardiac center" was reviewed.This research article reported a (b)(6)-year-old patient implanted with an amplatzer muscular vsd occluder.The patient developed persistent complete atrioventricular block(cavb) after the procedure and was sent to surgery to remove the occluder and surgically close the defect.The article confirmed the outstanding safety and efficacy benefits of transcatheter vsd closure in children and showed a minimal complication rate.The primary author of the article is saad q.Khoshhal, department of pediatrics, faculty of medicine, taibah university.The correspondance author is hany m.Abo-haded, md, department of pediatrics, faculty of medicine, mansoura university with the email hany_haded@yahoo.Com.

Manufacturer Narrative

Additional information for: g4, g7, h2, h6, and h10.As reported in a research article, a patient was implanted with a muscular vsd occluder and developed complete atrioventricular block so the device was explanted.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device was received for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: AMPLATZER MUSCULAR VSD OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 10865426
• MDR Text Key: 217089499
• Report Number: 2135147-2020-00480
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 4 YR