MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER VASCULAR PLUG II; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Catalog Number	9-AVP2-012
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2023
Type of Reportable Event	Malfunction
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) 2023, a 12mm amplatzer vascular plug ii was selected for an implant.The qa seal on the product box was intact and the product box containing the device did not appear damaged in any way.During the procedure, it was found there was a hole on the device under inoperative angiography.The procedure was stopped.The physician alleged that the cause of the hold on the plug was due to rubbing with the stent wire.Then the physician changed another unknown amplatzer vascular plug ii and complete the procedure.The patient is stable.
Additional Manufacturer Narrative
The reported event of a hole in device was confirmed.A hole is present in the central disc of amplatzer vascular plug ii; the forming hole is a result of the manufacturing process and does not impact the function of the device.The investigation confirmed the device met 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.The cause of the reported event is consistent with a forming hole which is considered to be a normal and acceptable characteristic of the device.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.H6.Medical device problem code - removed 1421 delivered as unsterile product, add 2976 material deformation.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The reported event of a hole in device was confirmed.A hole is present in the central disc of amplatzer vascular plug ii; the forming hole is a result of the manufacturing process and does not impact the function of the device.The investigation confirmed the device met 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.The cause of the reported event is consistent with a forming hole which is considered to be a normal and acceptable characteristic of the device.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• Brand Name: AMPLATZER VASCULAR PLUG II
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• 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: 17826192
• Report Number: 2135147-2023-04202
• Device Sequence Number: 6205228
• Product Code: KRD
• UDI-Device Identifier: 00811806010397
• UDI-Public: 00811806010397
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K071699
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 9-AVP2-012
• Device Lot Number: 8678838
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/04/2023
• Supplement Date Received by Manufacturer: 10/03/2023; 12/19/2023
• Initial Report FDA Received Date: 09/27/2023
• Supplement Report FDA Received Date: 10/26/2023; 12/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2022
• 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
• Patient Sex: Unknown