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

Model Number 9-VSD-MUSC-006

Device Problem Positioning Problem (3009)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/08/2019

Event Type  Injury  

Manufacturer Narrative

Further information regarding this event has been requested.The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

On (b)(6) 2019, a 4/6mm amplatzer duct occluder ii and a 6mm amplatzer muscular vsd occluder were selected to close an aortic to right ventricular fistula.While attempting to deploy both devices, the physician reported that both devices were unstable.The case was aborted due to difficulty closing the defect.Additional information has been requested.

Manufacturer Narrative

An event of an "unstable device" was reported.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 incident could not be conclusively determined.Please note per the instructions for use, (b)(4) rev b, " the amplatzer muscular vsd occluder is indicated for use in patients with a complex ventricular septal defect (vsd) of significant size to warrant closure who are considered to be at high risk for standard transatrial or transarterial surgical closure".

Event Description

On (b)(6) 2019, a 4/6mm amplatzer duct occluder ii and a 6mm amplatzer muscular vsd occluder were selected to close an aortic to right ventricular fistula.While attempting to deploy both devices, the physician reported that both devices were unstable.The case was aborted due to difficulty closing the defect.Since no additional information has been provided, we will proceed with closure.If additional information becomes available, the file will be reopened.

• 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: 8677037
• MDR Text Key: 147297890
• Report Number: 2135147-2019-00149
• 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: 07/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2020
• Device Model Number: 9-VSD-MUSC-006
• Device Catalogue Number: 9-VSD-MUSC-006
• Device Lot Number: 5313342
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/10/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2015
• 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): Hospitalization