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

Catalog Number	9-AVP2-010
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2023
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) 2023, a 10mm amplatzer vascular plug ii was chosen for implant in the left popliteal artery to ligate for a cardiopulmonary bypass surgery.During procedure, heparin was administered.The vessel was measured approximately 6.5mm, and the correct size was chosen.The 10mm amplatzer vascular plug ii was successfully deployed.A second 10mm amplatzer vascular plug ii was selected for deployment.While deploying the second plug, the plug embolized to the left pulmonary artery.There was no reported blockage of blood flow.A new 16mm amplatzer vascular plug ii was successfully deployed.After the deployment, the physician tried multiple attempts to retrieve the embolized plug, and the plug was successfully removed from the pulmonary artery via gooseneck snare.The removal of embolized plug was not an additional procedure and it was considered as emergency.The first and third plug remain implanted in the patient's leg.The patient was reported to be fine.
Event or Problem Description
It was reported that on (b)(6) 2023, a 10mm amplatzer vascular plug ii was chosen for implant in the left popliteal artery to ligate for a cardiopulmonary bypass surgery.During procedure, heparin was administered.The vessel was measured approximately 6.5mm, and the size of the device was determined via imaging.The 10mm amplatzer vascular plug ii was successfully deployed.A second 10mm amplatzer vascular plug ii was selected for deployment.While deploying the second plug, the plug embolized to the left pulmonary artery.There was no reported blockage of blood flow.A new 16mm amplatzer vascular plug ii was successfully deployed.After the deployment, the physician tried multiple attempts to retrieve the embolized plug, and the plug was successfully and emergently removed from the pulmonary artery via gooseneck snare.The first and third plug remain implanted in the patient's leg.The patient was reported to be stable.
Additional Manufacturer Narrative
An event of device embolism was reported.Two images were received from the field appearing to show the plug in the pulmonary artery and after removal from the body.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 incident could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• 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: 17606876
• Report Number: 2135147-2023-03700
• Device Sequence Number: 15029614
• Product Code: KRD
• UDI-Device Identifier: 00811806010380
• UDI-Public: 00811806010380
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K071699
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 10/05/2023

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 Catalogue Number: 9-AVP2-010
• Device Lot Number: 8828374
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/01/2023
• Supplement Date Received by Manufacturer: 09/19/2023
• Initial Report FDA Received Date: 08/23/2023
• Supplement Report FDA Received Date: 10/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2023
• 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: Life Threatening; Required Intervention
• Patient Age: 44 YR
• Patient Sex: Male
• Patient Weight: 81 KG