MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER TORQVUE DS; CATHETER, PERCUTANEOUS

Model Number	VSD MUSCULAR OCCLUDER
Medical Device Problem Codes	Retraction Problem (1536); Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on (b)(6) 2022, an 8mm amplatzer vsd muscular occluder was selected for implant using a 6f amplatzer itv delivery system.The device was sized using transthoracic echocardiogram (tte) and fluro imaging.During the procedure, the physician attempted to retrieve the device into the delivery sheath, however the second disc was not re-sheathing due to unknown causes.A cut down procedure from the jugular vein was performed and a larger sheath was placed inside the vein and the delivery sheath and device were pulled up using the larger sheath.The patient was hemodynamically stable throughout the procedure.A new 10mm amplatzer vsd muscular occluder was successfully implanted.The patient status was reported as unknown.
Additional Manufacturer Narrative
An event of difficulty in retrieving the amplatzer vsd muscular occluder back into the delivery sheath could not be confirmed.The investigation confirmed that the device met functional and visual specifications when analyzed at abbott under non-physiological conditions.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.No other complaints were reported on this batch.Based on the information received, the cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture design or labeling.D1, d2: device changed from amplatzer vsd to amplatzer torqvue delivery system.D4: lot number, catalog number, expiration date and udi have all been updated.D6: implant/explant dates removed.H4: manufacturing date updated.H6: medical device code 2682 (patient-device incompatibility) was removed.

• Brand Name: AMPLATZER TORQVUE DS
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG# 2135147; 5050 nathan ln n; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 15099578
• Report Number: 2135147-2022-00571
• Device Sequence Number: 4149462
• Product Code: DQY
• UDI-Device Identifier: 00811806010779
• UDI-Public: 00811806010779
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K072313
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2024
• Device Model Number: VSD MUSCULAR OCCLUDER
• Device Catalogue Number: 9-ITV06F180/80
• Device Lot Number: 8137914
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/03/2022
• Supplement Date Received by Manufacturer: 11/23/2022
• Initial Report FDA Received Date: 07/25/2022
• Supplement Report FDA Received Date: 11/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown