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

Model Number 9-VSD-MUSC-006

Device Problem Retraction Problem (1536)

Patient Problems Low Blood Pressure/ Hypotension (1914); Complete Heart Block (2627)

Event Date 07/18/2019

Event Type  Injury  

Event Description

Related manufacturer report number: 2135147-2019-00256.On (b)(6) 2019, an amplatzer muscular vsd occluder was selected for implant.The device was deployed but didn't fit the ventricular septal defect.The device was attempted to be retracted, but the occluder didn't collapse and retract into the delivery sheath.The tip of the delivery sheath kept folding in on itself.Meanwhile, the patient went into complete heart block and became hypotensive.The occluder and delivery system were withdrawn from the patient without collapsing the occluder.The procedure was cancelled and the patient was sent to the pediatric intensive care unit for continued monitoring.The heart block resolved without treatment.

Manufacturer Narrative

The reported event of difficulty retracting the device could not be confirmed.The investigation confirmed the device met functional and dimensional specifications when analyzed at abbott.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications at the time of commercialization.The cause of the reported event 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
• Manufacturer (Section G): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 8896643
• MDR Text Key: 154419245
• Report Number: 2135147-2019-00255
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806011790
• UDI-Public: 00811806011790
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: 9-VSD-MUSC-006
• Device Catalogue Number: 9-VSD-MUSC-006
• Device Lot Number: 5669757
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/13/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2016
• 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
• Treatment: AMPLATZER TORQVUE DELIVERY SYSTEM
• Patient Outcome(s): Other
• Patient Age: 5 YR