MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PULSAR-18 T3 6/100/135; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	430502
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The pulsar-18 t3 self-expandable stent system was selected for treatment of a mildly calcified lesion with 100 percent stenosis degree in the mildly tortuous mid sfa.After pre-dilatation, the stent was implanted in the target lesion.Inspection on the screen showed a fracture in the proximal part of the stent after inflation.Another pulsar-18 t3 6/40 stent was implanted to cover the fractured area.
Additional Manufacturer Narrative
The affected product was not returned.Therefore, no technical investigation on the subject could be performed.The production documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.In addition, the provided angiographic material and four photographs taken from the angiogram were reviewed.The angiographic material and the photographs provided show the stenosed sfa with several geometrically defined steps and edges along the medial sfa.The complaint stent is only visible after its release.The reported stent fracture was identified as a step in the patients anatomy, which the stent followed with its structure.The second implanted stent did follow this structure as well.A stent fracture could therefore not be confirmed.Geometric distortions of the stent structure are visible.A fish scale pattern in the medial stent portion was observed which might be indicative for application of tensile stress during stent release.Review of the production documentation confirmed that the device was manufactured according to specifications and fulfilled all the requirements of in-process and 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 root cause for the complaint event is most likely related to the patients anatomy.

• Brand Name: PULSAR-18 T3 6/100/135
• 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: 18243201
• Report Number: 1028232-2023-06068
• Device Sequence Number: 12405031
• Product Code: NIP
• UDI-Device Identifier: 07640130447004
• UDI-Public: (01)07640130447004(17)2607
• 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): 01/08/2024

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: 07/17/2026
• Device Model Number: 430502
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 07230116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 01/04/2024
• Initial Report FDA Received Date: 11/30/2023
• Supplement Report FDA Received Date: 01/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2023
• 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
• Patient Sex: Unknown