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

Model Number	9-AVP2-008
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results, method, and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
Related manufacturer report number: 2135147-2021-00142, 2135147-2021-00143.On (b)(6) 2021, a 8x6 mm amplatzer duct occluder was selected for implant in a (b)(6) month old child with a short and wide patent ductus arteriosus (pda).During the procedure, introduction of the catheter induced an arrhythmia and required cardioversion to resolve.Once the patient rhythm was returned to normal, the device was implanted and detached from the delivery cable in the pda.The device then was found to have embolized into the patients pulmonary artery.Another attempt was made with a 10x8 mm amplatzer duct occluder, but this device embolized as well.A third attempt was made with an 8 mm amplatzer vascular plug ii, but again the device embolized.All devices were removed and the procedure was aborted with no device implanted.The patient is stable with no adverse health consequences.The physician believes that the cause of the event was due to mis-sizing of device.
Additional Manufacturer Narrative
Additional information: g3, h2, h3, h6, and h10 an event of device embolization was reported.The investigation confirmed the device met functional and dimensional 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.

• Brand Name: AMPLATZER VASCULAR PLUG II
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 11675743
• Report Number: 2135147-2021-00144
• Device Sequence Number: 3157362
• Product Code: KRD
• UDI-Device Identifier: 00811806010373
• UDI-Public: 00811806010373
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K071125
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2025
• Device Model Number: 9-AVP2-008
• Device Catalogue Number: 9-AVP2-008
• Device Lot Number: 7443712
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/17/2021
• Supplement Date Received by Manufacturer: 04/27/2021
• Initial Report FDA Received Date: 04/15/2021
• Supplement Report FDA Received Date: 05/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AMPLATZER DUCT OCCLUDER; AMPLATZER DUCT OCCLUDER; AMPLATZER DUCT OCCLUDER; AMPLATZER DUCT OCCLUDER
• Outcome Attributed to Adverse Event: Required Intervention