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

Model Number	9-AVP2-006
Medical Device Problem Codes	Off-Label Use (1494); Detachment of Device or Device Component (2907); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a 6mm amplatzer vascular plug ii was selected for an implant on (b)(6), 2021 for a persistent ductus arteriosus which extends from the left subclavian to the aorta.The physician checked that the cable was tight on the occluder prior to used.During deployment, the plug was unscrewed from the cable.The left disc on the subclavian side deployed but not the right disc on the aortic side.The plug was in the canal but was not correctly positioned.The physician tried to recover and reposition the plug and was unsuccessfully.The physician tried to use a non-abbott device and went through the arterial way to recover the plug but was also unsuccessfully.The physician wanted to stabilize the plug so as not to risk having consequences for the patient.It was also impossible to recover the plug via the venous way since the plug was connected to the delivery sheath.Since the patient is (b)(6) the physician cannot change the sheath to a bigger size, too dangerous for the patient.The patient was sent to surgery and the plug was surgically removed.The patient remained hemodynamically stable throughout the procedure.It was reported that the patient was intubated and sent to the resuscitation room after the surgery.On (b)(6) 2021, it was reported that the patient was discharged from resuscitation and extubated.No additional information was provided.
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
Additional Manufacturer Narrative
An event of premature detachment of the plug was reported.A more comprehensive assessment could not be performed as the device was not returned for analysis.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.A capa was initiated for further investigation on the device detachment, per internal procedures.Please note, per the instructions for use, artmt600034447 revision b: "the safety and effectiveness of this device for cardiac uses (for example, patent ductus arteriosus or paravalvular leak closures) and neurological uses have not been established".

• Brand Name: AMPLATZER VASCULAR PLUG II
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 12775232
• Report Number: 2135147-2021-00457
• Device Sequence Number: 14982484
• Product Code: KRD
• UDI-Device Identifier: 00811806010366
• UDI-Public: 00811806010366
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K071125
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2022

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: 08/31/2024
• Device Model Number: 9-AVP2-006
• Device Catalogue Number: 9-AVP2-006
• Device Lot Number: 7165931
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2021
• Supplement Date Received by Manufacturer: 03/20/2022
• Initial Report FDA Received Date: 11/08/2021
• Supplement Report FDA Received Date: 03/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 19 DA
• Patient Sex: Unknown
• Patient Weight: 2 KG