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

Model Number	9-AVP2-008
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Off-Label Use (1494); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2022
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 vascular plug ii was successfully implanted to repair a patent ductus arteriosus (pda) using a 5f amplatzer torqvue lp delivery system.The device was well placed, the procedure was successful, and the patient was stable.There was no difficulty implanting the device.On (b)(6) 2022, a follow-up ultrasound as performed, and there was evidence of displacement of the device and leakage.There were no reports of any sudden movement or fall that may have accounted for this event.The device was then retrieved using a transcatheter snare.A replacement device, a 10mm amplatzer vascular plug ii, was then successfully implanted to resolve this event.The patient remained hemodynamically stable throughout the procedure.The patient has since been discharged.
Additional Manufacturer Narrative
An event of displacement of the device and leakage was reported.The device was returned to abbott for investigation and the device met visual and dimensional specifications when analyzed 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 defined manufacturing specifications.The cause of the reported incident could not be conclusively determined.Please note that per the instructions for use, artmt600034447-b, "the amplatzer¿ vascular plug and amplatzer¿ vascular plug ii are indicated for arterial and venous embolizations in the peripheral vasculature.".

• 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: 14636563
• Report Number: 2135147-2022-00353
• Device Sequence Number: 6085556
• Product Code: KRD
• UDI-Device Identifier: 00811806010373
• UDI-Public: 00811806010373
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: 9-AVP2-008
• Device Catalogue Number: 9-AVP2-008
• Device Lot Number: 6404726
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/10/2022
• Supplement Date Received by Manufacturer: 07/07/2022
• Initial Report FDA Received Date: 06/08/2022
• Supplement Report FDA Received Date: 08/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2018
• 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
• Concomitant Medical Products and Therapy/Usage Dates: AMPLATZER TORQVUE LP DS, 9-TVLP5F90/080.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 4 MO
• Patient Sex: Female
• Patient Ethnicity: Hispanic