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

Model Number	9-PDA2-05-04
Medical Device Problem Code	Difficult to Fold, Unfold or Collapse (1254)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported on (b)(6) 2025 a 5mm x 4mm amplatzer duct occluder ii was selected for implant using a 5f amplatzer torqvue low profile catheter.During the procedure the occluder took on a cobra shape.The occluder was not released from the delivery cable.The occluder was removed from the patient.There were no interactions with cardiac structures.There were no angulations or kinks noted on the delivery catheter.The patient remained hemodynamically stable throughout the procedure.There were no clinically significant delays to the procedure.There were no adverse signs or symptoms.The patient status was stable.
Additional Manufacturer Narrative
An event of device deformity was reported.The investigation at abbott found that there were no visible anomalies noted.The state of the returned component, due to the fracture damage, functional testing was precluded.The device was sent to science & technology lab (s&t) for further analysis, and it was found that multiple fractured wires were observed near a tangled region of wire at the edge of the proximal disc.Seven of the eight fractures observed on were tensile ductile failures.The eight appeared to be a shear where the wire crossed another.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.The root cause of the damaged wires could not be conclusively determined.There was no report of any interaction with cardiac structures during deployment and no report of any angulation/kink noticed with the delivery system.The cause of reported deformation could not be conclusively determined.The observed deformation is compatible with overstress of wires and could result from the same event or from later handling.Based on the evidence and data provided, the findings do not support a manufacturing origin and are consistent with post-abbott handling damage; therefore, the root cause of the complaint remains inconclusive.There were no complaints associated with any other devices from the lot.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
Event or Problem Description
It was reported on (b)(6) 2025, a 5mm x 4mm amplatzer duct occluder ii was selected for implant using a 5f amplatzer torqvue low profile catheter to treat a patent ductus arteriosus (pda).During the procedure the occluder took on a cobra shape.The occluder was not released from the delivery cable.The occluder was removed from the patient.There were no interactions with cardiac structures.There were no angulations or kinks noted on the delivery catheter.The patient remained hemodynamically stable throughout the procedure.There were no clinically significant delays to the procedure.There were no adverse signs or symptoms.The patient status was stable.

• Brand Name: AMPLATZER DUCT OCCLUDER II
• Common Device Name: OCCLUDER, PATENT DUCTUS, ARTERIOSUS
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG# 2135147; 5050 nathan ln n; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 22806669
• Report Number: 2135147-2025-04528
• Device Sequence Number: 15403295
• Product Code: MAE
• UDI-Device Identifier: 00811806011233
• UDI-Public: (01)00811806011233(17)250731(10)7642896
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P020024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2025
• Device Model Number: 9-PDA2-05-04
• Device Catalogue Number: 9-PDA2-05-04
• Device Lot Number: 7642896
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2025
• Supplement Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 08/14/2025
• Supplement Report FDA Received Date: 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5F AMPLATZER TORQVUE LP[9-TVLP5F90/080].
• Patient Sex: Unknown