MAUDE Adverse Event Report: ST. JUDE MEDICAL AMPLATZER PFO OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER

Model Number 9-PFO-035

Device Problems Patient-Device Incompatibility (2682); Biocompatibility (2886)

Patient Problems Erosion (1750); Cardiac Arrest (1762); Cardiac Tamponade (2226); Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 04/27/2021

Event Type  Death  

Manufacturer Narrative

An event of tissue erosion and patient death was reported.A more comprehensive assessment could not be performed as the device 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.

Event Description

It was reported that on (b)(6) 2021, a 35mm amplatzer patent foramen ovale (pfo) occluder was implanted with no known complications.On (b)(6) 2021, the patient presented to the emergency room (er) with cardiac arrest and cardiac tamponade.It was confirmed that the right disc eroded and the occluder was explanted.Information was also reported there was a repair was performed of the right femoral artery, right superficial artery, and the common femoral vein.There is no information regarding the relationship of the artery/vein repairs to the pfo occluder.In addition, drainage of pericardial fluid was performed.The patient was reported to be on extracorporeal membrane oxygenation (ecmo).It was reported that the patient passed away on (b)(6) 2021.Relevant imaging and operative reports were requested but the site was unable to provide.No additional information was provided.

• Brand Name: AMPLATZER PFO OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): ST. JUDE MEDICAL; 14901 deveau place; minnetonka MN 55345 2126
• Manufacturer (Section G): ST. JUDE MEDICAL; 14901 deveau place; minnetonka MN 55345 2126
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 12053881
• MDR Text Key: 257896683
• Report Number: 2182269-2021-00054
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806011301
• UDI-Public: 00811806011301
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P120021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9-PFO-035
• Device Catalogue Number: 9-PFO-035
• Device Lot Number: 7676564
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 59 YR