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

Model Number	9-AVP2-010
Medical Device Problem Codes	Difficult to Advance (2920); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	07/27/2022
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, a 10mm amplatzer vascular plug 2 was selected for an internal iliac artery embolization procedure.It was noted that during procedure the amplatzer vascular plug 2 was unable to be loaded through a 4.5fr parent guide catheter.The decision was made to replace the 4.5fr guide catheter with an unknown 7f guide catheter.The 10mm amplatzer vascular plug 2 was able to be loaded through the 7f guide catheter, but a thrombus adhered to the amplatzer vascular plug 2 preventing it from being able to advance to internal iliac artery.The decision was made to replace the 10mm amplatzer vascular plug 2 with a 12mm amplatzer vascular plug 2 to complete the procedure.There were no adverse patient effects reported.The patient was stable at the time of report.
Event or Problem Description
Subsequent to the previously filed report, additional information was received.It was reported that the 10mm amplatzer vascular plug 2 was able to advance through the non-abbott 4.5 fr guide catheter.However, there was difficulty positioning the plug because of the poor shape of the target vessel and it was unable to be partially recaptured.Therefore, the decision was made to remove the 4.5fr guide catheter and the 10mm amplatzer vascular plug 2 from the patient.A 7f non-abbott guide sheath was selected as a replacement for the 4.5 fr guide catheter, but when going to load the plug a thrombus was visually observed to have adhered to the plug.The patient was noted to have been administered heparin and had an activated clotting time of around 100 seconds.The patient was not taking any anti-coagulants prior to the procedure and no medication that could contribute to thrombus formation.The patient is not noted with having any hematologic disorders or systemic illness that could contribute to a hypercoagulability.A replacement 12mm amplatzer vascular plug 2 was successfully implanted using the 7f guide sheath.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in the procedure.The cause of thrombus formation is believed to be because he target vessel poor anatomy, so the device was not placed successfully, and the thrombus was formed during that time.
Additional Manufacturer Narrative
An event of thrombus adhering to an amplatzer vascular plug ii and thus preventing advancement of the device into the internal iliac artery was reported.The device was returned to abbott for investigation and 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.Based on the information received, the cause of the reported incident could not be conclusively determined but could have been related to the fact that no heparin was administered during the procedure.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.H6: medical device code 2920 (difficult to advance) was removed.

• 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 lane north; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 15271683
• Report Number: 2135147-2022-00858
• Device Sequence Number: 5871618
• Product Code: KRD
• UDI-Device Identifier: 00811806010380
• UDI-Public: 00811806010380
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 11/23/2022

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 Model Number: 9-AVP2-010
• Device Catalogue Number: 9-AVP2-010
• Device Lot Number: 8368971
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/27/2022
• Supplement Date Received by Manufacturer: 11/17/2022
• Initial Report FDA Received Date: 08/22/2022
• Supplement Report FDA Received Date: 11/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 4.5FR PARENT GUIDE CATHETER; UNKNOWN 7F GUIDE CATHETER
• Outcome Attributed to Adverse Event: Other
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 53 KG