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

Model Number	9-AVP2-016
Medical Device Problem Codes	Fracture (1260); Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2023
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 16mm amplatzer vascular plug ii was chosen for implant with an unknown delivery system.During procedure, it was noted via intraoperative angiography there was a hole in the device.A decision was made to remove the device and replaced with another amplatzer vascular plug ii.The first device was never released from the delivery cable while inside the patient.There was no fracture/breakage of the nitinol wires on the device and there was no note of packaging damage prior to use.It was reported the patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in the procedure due to this event and the patient status was reported as stable.
Additional Manufacturer Narrative
An event of a hole being noted in the device via intraoperative angiography.One image was received appearing the show the hole in the device.The device was returned to abbott for analysis.The reported event of a hole in device was confirmed; the forming hole is a result of the manufacturing process.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 were no complaints associated with any other devices from the lot.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: 16981355
• Report Number: 2135147-2023-02248
• Device Sequence Number: 12455367
• Product Code: KRD
• UDI-Device Identifier: 00811806010410
• UDI-Public: 00811806010410
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K071699
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 07/20/2023

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 Expiration Date: 02/29/2024
• Device Model Number: 9-AVP2-016
• Device Catalogue Number: 9-AVP2-016
• Device Lot Number: 6885848
• 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: 04/27/2023
• Supplement Date Received by Manufacturer: 07/06/2023
• Initial Report FDA Received Date: 05/22/2023
• Supplement Report FDA Received Date: 07/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/04/2019
• 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