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	Pulmonary Edema (2020)
Date of Event	05/14/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Further information was requested but not received.The results, method, and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
It was reported that on (b)(6) 2021, a 8 mm amplatzer vascular plug ii was successfully implanted in a patients patent ductus arteriosus (pda) with high cardiac output heart failure.Post-procedure, while the patient was receiving echocardiogram.It was noted that the device had embolized from the patent ductus arteriosus (pda) to the left pulmonary artery (lpa).The patient was brought back to cardiac cath lab, where the embolized device was retrieved, and a 10mm abbott vascular plug 2 was implanted in the pda.The patient is stable.No additional information provided.
Additional Manufacturer Narrative
An event of off label use of the device and device embolism post procedure 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.
Event or Problem Description
User facility medwatch received that states that on (b)(6) 2021, a 8 mm amplatzer vascular plug ii was successfully implanted in a patients patent ductus arteriosus (pda) with high cardiac output heart failure.Post-procedure, while the patient was receiving echocardiogram.It was noted that the device had embolized from the patent ductus arteriosus (pda) to the left pulmonary artery (lpa).The patient was brought back to cardiac cath lab, where the embolized device was retrieved, and a 10mm abbott vascular plug 2 was implanted in the pda.The patient is stable.No additional information provided.

• 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: 12514428
• Report Number: 2135147-2021-00378
• Device Sequence Number: 3487926
• Product Code: KRD
• UDI-Device Identifier: 00811806010373
• UDI-Public: 00811806010373
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2021

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: 02/28/2026
• Device Model Number: 9-AVP2-008
• Device Catalogue Number: 9-AVP2-008
• Device Lot Number: 7868672
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/24/2021
• Supplement Date Received by Manufacturer: 10/19/2021
• Initial Report FDA Received Date: 09/22/2021
• Supplement Report FDA Received Date: 11/02/2021
• 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; Required Intervention
• Patient Age: 4 MO