MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PULSAR-18 T3 6/200/135; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	430506
Medical Device Problem Codes	Malposition of Device (2616); Material Deformation (2976); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A pulsar-18 t3 self-expandable stent system was selected for treatment for a severely calcified lesion in the sfa.At the moment of the deployment, after having pulled back the stent because of minor physiological jumping of the device when releasing the first struts, the shaft started moving distally, ending up with compression of the stent and proximal misalignment/shortening.This 6x200mm stent was finally deployed at a length of roughly 170mm.An additional pulsar 6x60mm was deployed proximally to cover the proximal diseased part left.
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.In addition, the provided images and the provided video of the angiogram were reviewed.The photographs provided shows the sfa in different stages of the intervention.No details about geometrical distortions of the stent are visible.The video provided shows the positioning and the release of the complaint stent.It is visible, that the retractable shaft is pulled back, whereas the inner shaft is pushed forward, resulting in the position at the distal end of the stent to be correct, whereas the position of the proximal end of the stent is shifted by several centimeters.This is indicative for the presence of a slack in the delivery system outside of the body during the release attempt.The technical investigation of the returned device confirmed that the stent has been fully released.The outer shaft has been retracted by about 232 mm.Besides a kink 15 mm proximal to the distal x-ray marker no damage or irregularity was observed.Review of the production documentation confirmed that the device was manufactured according to specifications and passed all in-process and final inspections.Based on the conducted investigations no manufacturing related root cause was determined.The most probable root cause for the complaint event is related to the handling during the procedure.Please note that, according to the ifu, any slack in the delivery system outside the patient could result in incorrect stent placement, potential stent compression or elongation.

• Brand Name: PULSAR-18 T3 6/200/135
• 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: 20903454
• Report Number: 1028232-2024-06394
• Device Sequence Number: 14703855
• Product Code: NIP
• UDI-Device Identifier: 07640130447042
• UDI-Public: (01)07640130447042(17)2704
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P160025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2025

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: 430506
• Device Catalogue Number: 430506
• Device Lot Number: 03241820
• 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: 12/04/2024
• Supplement Date Received by Manufacturer: 02/12/2025
• Initial Report FDA Received Date: 12/11/2024
• Supplement Report FDA Received Date: 02/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/02/2024
• 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