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

Model Number	9-AVP2-022
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/15/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2018, a 22mm amplatzer vascular plug ii (avp2) was used as a demonstration device prior to procedure to refresh the physicians on device preparation and deployment.During device preparation, slight resistance was encountered when the loader was backed into the sheath and when the plug was advanced smoothly into the sheath.The device was deployed in the patient, and the wire tip detached and remained attached to the proximal marker of the plug.After multiple attempts, the device was not occluding; however, the device was still released and left implanted with the wire still attached.Twenty-five minutes later, fluoroscopy showed blood flow, and the patient's platelets were a bit low, however no lab test was performed for exact numbers.A follow-up visit is planned to see whether the device occluded blood flow.There were no patient consequences.
Additional Manufacturer Narrative
Events of "a piece of wire remained attached to the proximal marker of the plug" and occlusion issue were reported.The results of the investigation are inconclusive since the device was not returned for analysis and remains implanted; however, two images were submitted for evaluation.Visual inspection was based solely upon a review of the images received.The images were captured under fluoroscopy and appeared to show a vascular plug with an unknown object engaged in the end screw.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: AMPLATZER VASCULAR PLUG II
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 8047787
• Report Number: 2135147-2018-00205
• Device Sequence Number: 1683782
• Product Code: KRD
• UDI-Device Identifier: 00811806010441
• UDI-Public: 00811806010441
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K071125
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: 9-AVP2-022
• Device Catalogue Number: 9-AVP2-022
• Device Lot Number: 6540827
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/15/2018
• Supplement Date Received by Manufacturer: 01/30/2019
• Initial Report FDA Received Date: 11/07/2018
• Supplement Report FDA Received Date: 02/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization