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

Model Number VSDMUSCPI-022-01

Device Problems Migration or Expulsion of Device (1395); Detachment of Device or Device Component (2907)

Patient Problem Death (1802)

Event Type  Death  

Manufacturer Narrative

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

Event Description

On (b)(6) 2020, a 22mm amplatzer occluder was selected for implant.The device was advanced through the 12 fr delivery system from through the defect, which was very apical.As the device was deployed, the left ventricular disc deployed with no issue.As the device was being pulled into the defect (delivery system and device together) the device came off the end of the delivery cable and became free into the left ventricle.An unsuccessful attempt was made to snare the device during which time the patient became unstable, requiring cpr, and passed away.

Manufacturer Narrative

An event of the device prematurely detaching and patient death was reported.A more comprehensive assessment could not be performed as the device remains implanted was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: AMPLATZER P.I. 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: 11012820
• MDR Text Key: 221706449
• Report Number: 2135147-2020-00541
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: VSDMUSCPI-022-01
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death