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

Model Number 9-PDA-006

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/05/2021

Event Type  Injury  

Manufacturer Narrative

Further information regarding this event has been requested.The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

On (b)(6) 2021, a 6mm amplatzer duct occluder as selected for implant.Post implant it was reported that the device embolized from a paravalular leak (pvl) due to an unknown mechanical valve.The device was snared successfully using a 12f trevisio and a ensare gooseneck snare.A new 9mm amplatzer duct occluder was successfully implanted.The patient was reported to be in stable condition.

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: 11805301
• MDR Text Key: 249986948
• Report Number: 2135147-2021-00185
• Device Sequence Number: 1
• Product Code: MAE
• UDI-Device Identifier: 00811806011134
• UDI-Public: 00811806011134
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 06/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9-PDA-006
• Device Catalogue Number: 9-PDA-006
• Device Lot Number: 7662619
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 70