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

Model Number	9-AVP2-012
Medical Device Problem Codes	Difficult to Advance (2920); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2022, a 12mm amplatzer vascular plug ii was chosen for implant with a 6fr non-abbott delivery sheath.The device was unable to go through the 6fr sheath while it was in the catheter so a 7fr non-abbott sheath was attempted to be used as a replacement.During the process of switching to the new sheath the device fell of the wire and could no longer be used.The device was replaced with a 14mm amplatzer vascular plug ii using the 7fr non-abbott sheath.During the implant process it was discovered that the 14mm device was too big.It was removed and replaced with a 10mm device using the same 7fr non-abbott sheath and a non-abbott (jr4) guide catheter.The patient did not have a tortuous anatomy.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.
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 difficulty deploying the device was reported.A returned device 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 event could not be conclusively determined.

• 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: 15996430
• Report Number: 2135147-2022-02613
• Device Sequence Number: 6151179
• Product Code: KRD
• UDI-Device Identifier: 00811806010397
• UDI-Public: 00811806010397
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2023

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: 02/28/2025
• Device Model Number: 9-AVP2-012
• Device Catalogue Number: 9-AVP2-012
• Device Lot Number: 7440910
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/29/2022
• Supplement Date Received by Manufacturer: 01/25/2023
• Initial Report FDA Received Date: 12/16/2022
• Supplement Report FDA Received Date: 01/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2020
• 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 VASCULAR PLUG, 9-AVP2-010, LOT 764118.; AMPLATZER VASCULAR PLUG, 9-AVP2-012, LOT 7440910.
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 77 KG