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

Catalog Number	600028870
Medical Device Problem Codes	Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on 25 october 2023, an amplatzer vascular plug ii was chosen for implant into aortic paravalvular leak (pvl) in the non-coronary cusp.It was indicated that there was a pre-existing 23mm non-abbott aortic valve implanted.A 12mm amplatzer vascular plug ii was advanced through 6f non-abbott guide sheath (inner diameter 0.070").However, about 20cm into the guide, resistance was met, and the device could not be advanced further.The device was removed and was noted to have a hold in the central disc portion of the devices.A replacement same size plug was used with the same 6f non-abbott guide sheath (guide not changed at that time); however, the same issue occurred.There was no tortuosity to explain this.Thus, the guide size was increased to 7f non-abbott guide sheath (inner diameter 0.081") given that inner diameter was the same as the minimum required for the device.At about 50cm into the guide sheath, the device would not advance any further.Similar outcome with a hole in the shoulder of the central disc of the avp-2.Another 7f guide was bench tested on the back table (note this was a cordis 7f guide).There was no resistance to advancing the device.After discussion, the guide sheath was upsized to an 8f non-abbott guide sheath (0.091").A larger avp2 (10mm or 12mm) could not be advanced despite a significantly larger inner diameter than required.The device was able to be advanced through the guide sheath closer to 75cm.Similar problem with the whole in the device after removal.Finally i took a smaller amplatzer plug (08mm amplatzer vascular plug ii) than desired based on the lesion size (8mm) and was able to advance this with extreme difficulty through the 8f guide.A hemostat was needed to be used every 2-3mm to advance the device for the last 10cm of the guide.Eventually we were successful in delivering the device.The patient had no residual pvl, and the device did not embolize.The patient remained hemodynamically stable throughout the procedure.This issue reportedly caused a clinically significant delay, but the delay did not result in adverse patient sequelae.
Additional Manufacturer Narrative
An event of difficulty inserting the device through the guide sheath was reported.A returned device inspection, to rule out any device-related causes, could not be performed as the device was not returned for analysis.Information from field indicated that the nitinol wire was tearing the sides of the guide sheath.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 available information, a cause for the reported event could not be 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: 18310495
• Report Number: 2135147-2023-05438
• Device Sequence Number: 12300162
• Product Code: KRD
• UDI-Device Identifier: 00811806010397
• UDI-Public: 00811806010397
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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
• Report Date (Section B): 12/12/2023

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: 03/31/2025
• Device Catalogue Number: 600028870
• Device Lot Number: 7474984
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/15/2023
• Initial Report FDA Received Date: 12/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2020
• 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
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 65 KG