MAUDE Adverse Event Report: ST. JUDE MEDICAL (CVD-PLYMOUTH) AMPLATZER P.I. MUSCULAR VSD OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER

Model Number 9-VSDMUSCPI-016

Device Problem Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/01/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a 16mm amplatzer p.I.Muscular vsd occluder was selected for an implant on (b)(6) 2022.The device was delivered into a complex ventricular septal defect (vsd) that had two tracts.An inferior narrower and a superior wider tract which had a common origin in left ventricle.Initially the inferior tract was cannulated and the device was deployed.The shape was noted to be distorted and it was thought that this was due to long thin tract.The physicians decided the superior tract would be more appropriate and the disc may then be in close origin to inferior tract.While one physician was cannulating superior tract, another physician flushed trevisio sheath and occluder.When the physician advance the device it was noted that proximal disc was very deformed that appeared like cobra head.A new 16mm amplatzer p.I.Muscular vsd occluder was prepped and delivered.Deployed uneventfully and with excellent fluoro and echo result.Patient stable, no additional information was provided.

Manufacturer Narrative

An event of cobra deformation was reported.A more comprehensive assessment could not be performed as the device was not returned for analysis; however, five photos were received for analysis.Based solely on the aforementioned photos, the occluder appeared to present in cobra deformation after being deployed within the patient.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): ST. JUDE MEDICAL (CVD-PLYMOUTH); 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL (CVD-PLYMOUTH); 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 13582162
• MDR Text Key: 286649143
• Report Number: 3005334138-2022-00086
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 03/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: 9-VSDMUSCPI-016
• Device Lot Number: 6879603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2019
• 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 Age: 71 YR
• Patient Sex: Female