MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PULSAR-18 T3 6/40/135; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	430499
Medical Device Problem Codes	Fracture (1260); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The pulsar-18 t3 stent system was chosen for the treatment.The stent failed to detach originally, caught on struts when removing.Another stent was used, and the intervention was successfully completed.
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 multiple severe damages at the delivery system.The outer shaft has been fully retracted and the stent has been released which confirms functionality of the release mechanism.However, the outer shaft has been retracted too far, causing compression of the stabilizer shaft which may have contributed to the issues during device withdrawal.The stabilizer shaft further shows surface abrasions and a strong kink at the transition to the handle lever.In addition, both the outer shaft and the inner shaft have fractured.The fracture sites are plastically deformed which is indicative for the application of a high tensile force.The introducer sheath and the guidewire used in the intervention were not returned.Review of the production documentation confirmed that the device in question was manufactured according to specifications and successfully passed all in-process controls as well as the final inspection.Based on the conducted investigations of the device being subject to this complaint, no material or manufacturing related root cause could be determined.The cause for the reported stent release issues could not be established.

• Brand Name: PULSAR-18 T3 6/40/135
• 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: 20780004
• Report Number: 1028232-2024-06119
• Device Sequence Number: 21069985
• Product Code: NIP
• UDI-Device Identifier: 07640130446977
• UDI-Public: (01)07640130446977(17)2703
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P160025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2025

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: 430499
• Device Catalogue Number: 430499
• Device Lot Number: 03241453
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2024
• Supplement Date Received by Manufacturer: 01/08/2025
• Initial Report FDA Received Date: 11/26/2024
• Supplement Report FDA Received Date: 01/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/27/2024
• 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 Age: 68 YR
• Patient Sex: Male