AMPLATZER DUCT OCCLUDER
Received Jul 10, 2026 · Event occurred Jun 18, 2026
Report 2135147-2026-04779 · MDR key 25785542
Device
Generic name
Occluder, Patent Ductus, Arteriosus
Manufacturer
Abbott MedicalModel number
9-PDA-007Catalog number
9-PDA-007
Lot number
10035583
Product problems
- Product Quality Problem
- Patient Device Interaction Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.
Description of Event or Problem
IT WAS REPORTED THAT ON (B)(6) 2026, A 12-10MM AMPLATZER PDA OCCLUDER WAS CHOSEN FOR IMPLANT USING AN UNKNOWN DELIVERY SYSTEM. DURING THE PROCEDURE, AFTER AN INITIAL ATTEMPT AT CLOSURE, A RESIDUAL SHUNT WAS OBSERVED. THE DEVICE WAS SUBSEQUENTLY RETRIEVED AND EXAMINED OUTSIDE THE BODY, AT WHICH TIME MULTIPLE INSTANCES OF FABRIC ENTANGLEMENT WERE NOTED. DUE TO THESE FINDINGS, THE INITIAL DEVICE WAS NOT RE-USED, AND THE PROCEDURE WAS COMPLETED USING AN ALTERNATIVE ADO-1 DEVICE.