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

Model Number	9-AVP2-022
Medical Device Problem Codes	Use of Device Problem (1670); Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
Event or Problem Description
On (b)(6) 2020, a 22mm amplatzer vascular plug ii was selected for implant to occlude a portal vein.The plug was prepared per the ifu and released from the cable.However, post-implant, the plug was observed to occlude the inferior vena cava (ivc).Therefore, the plug was snared and removed from the patient.A new competitor's asd device was successfully implanted.A clinically significant delay in the procedure time was reported.The patient was reported to be in stable condition.
Additional Manufacturer Narrative
An event of the plug occluding the inferior vena cava in addition to the target vein was reported.A more comprehensive 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.
Additional Manufacturer Narrative
An event of plug occluded the inferior vena cava (ivc) was reported.The investigation confirmed the device met dimensional 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 event 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: 11278724
• Report Number: 2135147-2021-00031
• Device Sequence Number: 11410551
• Product Code: KRD
• UDI-Device Identifier: 00811806010441
• UDI-Public: 00811806010441
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K0701699
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/07/2021

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: 12/31/2024
• Device Model Number: 9-AVP2-022
• Device Catalogue Number: 9-AVP2-022
• Device Lot Number: 7333369
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/15/2021
• Supplement Date Received by Manufacturer: 03/17/2021; 09/30/2021
• Initial Report FDA Received Date: 02/04/2021
• Supplement Report FDA Received Date: 03/22/2021; 10/07/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention