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

Model Number	9-AVP2-014
Medical Device Problem Codes	Inflation Problem (1310); Activation Failure (3270)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Further information regarding this event has been requested.The investigation results will be provided in a subsequent submission.
Event or Problem Description
On (b)(6) 2020, a 14mm amplatzer vascular plug ii(avpii) was selected for embolization of iia(internal iliac artery) via femoral approach, using a guiding sheath(destination by terumo).The distal lobe of the three lobes was deployed normally.However, the distal part of the mid lobe did not expand.The avpii was withdrawn into the sheath and re-deployed a few times, but the issue persisted.Another 14mm avpii was able to be deployed normally to embolize the artery successfully.The procedure was completed with no adverse consequence to the patient.When the avpii was checked outside of the patient after the procedure, the avpii expanded with no problem.Although the issue was not duplicated outside of the patient, the physician and the sales rep.Thought the issue was due to the avpii itself, for the replacement avpii was able to be deployed successfully.
Additional Manufacturer Narrative
Additional information: d10, h3, h6.The reported event of device deformation could not be confirmed.The investigation confirmed the device met visual and functional specifications when analyzed at abbott.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The cause of the reported incident could not be conclusively determined.
Event or Problem Description
On (b)(6) 2020, a 14mm amplatzer vascular plug ii(avpii) was selected for embolization of iia(internal iliac artery) via femoral approach, using a guiding sheath(destination by terumo).The distal lobe of the three lobes was deployed normally.However, the distal part of the mid lobe did not expand.The avpii was withdrawn into the sheath and re-deployed a few times, but the issue persisted.Another 14mm avpii was able to be deployed normally to embolize the artery successfully.The procedure was completed with no adverse consequence to the patient.When the avpii was checked outside of the patient after the procedure, the avpii expanded with no problem.Although the issue was not duplicated outside of the patient, the physician and the sales rep.Thought the issue was due to the avpii itself, for the replacement avpii was able to be deployed successfully.

• 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: 10127501
• Report Number: 2135147-2020-00255
• Device Sequence Number: 2153156
• Product Code: KRD
• UDI-Device Identifier: 00811806010403
• UDI-Public: 00811806010403
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K071125
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2020

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: 04/30/2024
• Device Model Number: 9-AVP2-014
• Device Catalogue Number: 9-AVP2-014
• Device Lot Number: 6994141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/11/2020
• Supplement Date Received by Manufacturer: 06/03/2020
• Initial Report FDA Received Date: 06/08/2020
• Supplement Report FDA Received Date: 06/25/2020
• 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