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

Model Number 9-VSD-MUSC-014

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Myocardial Infarction (1969)

Event Date 02/11/2022

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

It was reported on (b)(6) 2022, a 14mm amplatzer muscular vsd occluder was selected for implant.A few seconds after release the device embolized into the tricuspid valve and was not able to be snared.A few days prior, the patient suffered myocardial infraction and due to the patient's overall health condition it was decided to leave the occluder and not explant it until the patient recovers.It is thought that the embolization occurred due to the cardiac infraction and the tissue of the ventricle septum was perished and caused a ventricular septal defect (vds).The rims of the septum were to weak to stabilize the occluder.The physician reported that this was a known possibility after the recent infraction.The patient did not experience any adverse health consequences and the patient was reported to be to recovering.Operative notes and echo images were required but cannot be provided due to data security restrictions.

Manufacturer Narrative

An event of embolization was reported.A more comprehensive assessment could not be performed as the device remains implanted and 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 MUSCULAR VSD OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 13548258
• MDR Text Key: 285732769
• Report Number: 3005334138-2022-00123
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806011837
• UDI-Public: 00811806011837
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P040040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9-VSD-MUSC-014
• Device Catalogue Number: 9-VSD-MUSC-014
• Device Lot Number: 7362857
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2020
• 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