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

Model Number	9-PDA-005
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Premature Separation (4045)
Health Effect - Clinical Code	Coronary obstruction/occlusion (4871)
Date of Event	02/06/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on (b)(6) 2025, a 8-6mm amplatzer duct occluder was chosen for a patent ductus arteriosus (pda) closure using a 6f amplatzer torqvue delivery system.The size of the defect was 4mm computed tomography (ct) visualization was difficult on angiography looked to be close to 4 mm around 12 mm aortic ampulla on ct and again agio difficult on aortic ampulla.The device was prepared in standard fashion and the physician verified the device was just unlocked off click before attempting placement.During procedure, the placement was difficult due to limited visualization of the pda and the device during deployment.The fluoroscopy (fluro) image was a bit gray during the duration of the procedure and the device was under counter traction with the catheter occasionally sliding on the cable with heart contractions.The device fell of the cable of the delivery system and embolized to the patient left femoral artery and there was partial obstruction/blockage of blood flow.There was no direct visualization of the device coming off the cable it occurred in between fluoroscopy images.A new 6mm by 6mm amplatzer duct occluder ii, a cable form the amplatzer torqvue lp delivery system and new 6f catheter form amplatzer torqvue delivery system were chosen.The physician decided to use that technique due to avoid placing another catheter in the pda and loosing his current position and potentially exposing the patient to additional risk.The second device was prepared in a similar fashion the first device and remained on the cable and placed well.A slight increase in the frame rate of the fluoro was made from 20 frames/sec to 30 frames per second.The ductus was closed via placement of the pulmonary artery (pa) disk in the pa and the remainder of the device placed in the ductus.Two15mm non-abbott snares were used to retrieve the embolized device from the left femoral artery.Due to the disk of the device being on the proximal end of a triforcation of the femoral artery the physician was chose a alligator bioptome due to inability to snare with a conventional snare.The retrieval process took about 1 additional hour on the procedure time and the device was successfully removed.The patient remained hemodynamically stable throughout the duration of the procedure and experienced no adverse events as a result of the embolized device.The patient's post procedure care was planned to be standard post closure.
Additional Manufacturer Narrative
An event of migration or expulsion of device (device embolization) and premature separation was reported.A returned device 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.Additionally, a review of the complaint history identified no similar incidents reported from this lot.Based on the information received, a cause for the reported device premature separation could not be determined.The reported device embolization resulted in coronary obstruction/occlusion (partial obstruction/blockage of blood flow) appears to be related to the premature separation of the device.The reported unexpected medical intervention was a result of case-specific circumstances.There is no indication of a product quality issue with regards to manufacture, design, or labeling.Codes removed: health effect-clinical code: type of investigation: 4118 type of investigation not yet determined; investigation findings: investigation conclusions: 11 conclusion not yet available.

• Brand Name: AMPLATZER DUCT OCCLUDER
• 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: 21506844
• Report Number: 2135147-2025-01079
• Device Sequence Number: 17255412
• Product Code: MAE
• UDI-Device Identifier: 00811806011127
• UDI-Public: (01)00811806011127(17)280731(10)9179191
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 9-PDA-005
• Device Catalogue Number: 9-PDA-005
• Device Lot Number: 9179191
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/06/2025
• Supplement Date Received by Manufacturer: 03/25/2025
• Initial Report FDA Received Date: 03/03/2025
• Supplement Report FDA Received Date: 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/05/2023
• 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: 6F AMPLATZER TORQVUE DELIVERY SYSTEM, 9-ITV06F180/
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male