MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER DUCT OCCLUDER; OCCLUDER, PATENT DUCTUS, ARTERIOSUS

Model Number 9-PDA-005

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

Patient Problem Arrhythmia (1721)

Event Type  Injury  

Manufacturer Narrative

The results, method, and conclusion codes along with investigation results will be provided in the final report.

Event Description

Related manufacturer report number: 2135147-2021-00143, 2135147-2021-00144.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.

Manufacturer Narrative

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 DUCT OCCLUDER
• Type of Device: OCCLUDER, PATENT DUCTUS, ARTERIOSUS
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 11675731
• MDR Text Key: 246003449
• Report Number: 2135147-2021-00142
• Device Sequence Number: 1
• Product Code: MAE
• UDI-Device Identifier: 00811806011127
• UDI-Public: 00811806011127
• Combination Product (y/n): N
• PMA/PMN Number: P020024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9-PDA-005
• Device Catalogue Number: 9-PDA-005
• Device Lot Number: 7362816
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AMPLATZER DUCT OCCLUDER; AMPLATZER VASCULAR PLUG II
• Patient Outcome(s): Required Intervention