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

Model Number 9-AVP2-008

Device Problems Migration or Expulsion of Device (1395); Off-Label Use (1494)

Patient Problem Pulmonary Edema (2020)

Event Date 05/14/2021

Event Type  Injury  

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 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.

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 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
• Type of Device: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 12514428
• MDR Text Key: 272971425
• Report Number: 2135147-2021-00378
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 00811806010373
• UDI-Public: 00811806010373
• Combination Product (y/n): N
• PMA/PMN Number: K071125
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 11/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 10/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 4 MO