MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PULSAR-18 T3 6/60/90; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	430460
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The pulsar-18 t3 peripheral self-expandable stent system was selected for treatment of a severely calcified lesion with 10 percent stenosis degree in the sfa.After pre-dilatation, the device got stuck inside the lesion.Another pulsar-18 t3 was used and implanted successfully.
Additional Manufacturer Narrative
The returned product was subjected to a detailed technical analysis and the corresponding production documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for this event.The technical investigation revealed severe scratches and indentations at the tip and the distal end of the retractable shaft which most likely originate from the patients anatomy.The device shaft slightly bulged about 6 mm proximal to its distal end.Outside of the deformed zones, the diameter of the retractable shaft complies with the specification.After flushing, a 0.018 inch reference guidewire could be fully introduced with no unusual resistance.The guidewire and the introducer sheath used in the intervention were not returned.A reference 4f 12 cm abbott ultimum introducer sheath was measured to be 1.48 mm inner diameter.The complaint device could be introduced into this reference introducer sheath with no issues, despite of the bulge in the device shaft.Review of the production documentation confirmed that the device was manufactured according to specifications and passed all in-process and final inspections.During final inspection, every stent system undergoes visual inspection, and the outer shaft diameter is measured to 100 percent.Based on the conducted investigations of the device being subject to this complaint, no material or manufacturing related root cause could be determined.The presence of the scratches on the device tip shows that the patients anatomy might have been a contributing factor for the reported complaint event.However, it cannot be reconstructed if the bulging of the device shaft was induced during the lesion crossing attempt or during accessing through the introducer sheath.

• Brand Name: PULSAR-18 T3 6/60/90
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): BIOTRONIK AG, BUELACH, SWITZERLAND; ackerstrasse 6; buelach CH-81 80; CH CH-8180
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 20979102
• Report Number: 1028232-2024-06545
• Device Sequence Number: 11811176
• Product Code: NIP
• UDI-Device Identifier: 07640130446588
• UDI-Public: (01)07640130446588(17)2709
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P160025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2025

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 Model Number: 430460
• Device Catalogue Number: 430460
• Device Lot Number: 09241358
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2024
• Supplement Date Received by Manufacturer: 02/10/2025
• Initial Report FDA Received Date: 12/19/2024
• Supplement Report FDA Received Date: 02/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2024
• 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
• Patient Sex: Unknown