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

Model Number	9-AVP2-012
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Clinical information: crd_1008 - av-mdr, patient site id: (b)(6).It was reported that on (b)(6) 2022, a 12mm amplatzer vascular plug ii was chosen for implant.Prior to 12mm device implant, a 10mm amplatzer vascular plug ii (8372531) was successfully implanted.While attempting to implant the 12mm device (8368984), device deployment was successful, however, after the device was in place, it came out.Leakage was seen around the plug and considered clinically acceptable.Afterwards, a second 10mm amplatzer vascular plug ii (7810738) was successfully implanted.No additional information was provided.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of residual shunt after placement of the device and explant was reported.Information from the field indicated that after the device implanted it popped out of the pvl.A returned device assessment could not be performed as the device was not returned for analysis.No additional information has been provided by the field.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.
Event or Problem Description
Clinical information: crd_1008 - av-mdr, patient site id: (b)(6).It was reported that on (b)(6) 2022, a 12mm amplatzer vascular plug ii was chosen for implant to plug a paravalvular leak (pvl).Prior to 12mm device implant, a 10mm amplatzer vascular plug ii (8372531) was successfully implanted in another nearby pvl.While attempting to implant the 12mm device (8368984), device deployment was successful.However, leakage was seen around the plug and after the device was in place, it popped out of the pvl.Afterwards, the device was explanted and a second 10mm amplatzer vascular plug ii (7810738) was successfully implanted.The patient was reported as stable.

• 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: 16897452
• Report Number: 2135147-2023-02001
• Device Sequence Number: 20322563
• Product Code: KRD
• UDI-Device Identifier: 00811806010397
• UDI-Public: 00811806010397
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K071699
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2023

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 Model Number: 9-AVP2-012
• Device Catalogue Number: 9-AVP2-012
• Device Lot Number: 8368984
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/14/2023
• Supplement Date Received by Manufacturer: 07/26/2023
• Initial Report FDA Received Date: 05/09/2023
• Supplement Report FDA Received Date: 08/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2022
• 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 Age: 31 YR
• Patient Sex: Male
• Patient Weight: 73 KG