MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PULSAR-18 T3 5/40/135; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	430489
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A pulsar-18 self-expandable stent system was selected for treatment.After successful stent implantation, when pulling back the delivery system, a piece broke off, but could be retrieved.
Additional Manufacturer Narrative
The returned product was subjected to a detailed technical analysis and the corresponding product release documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for this event.The technical investigation confirmed that the inner shaft has fractured and separated from the stent system.The separated inner shaft fragment has a length of about 154 mm and is plastically deformed (i.E.Elongated and has calibrated down).The analysis further revealed severe deformations (i.E.Compressions) of the retractable shaft in its distal portion and at its very distal end which shows that at some point high resistance was met.Outside of the deformed zone the diameter of the retractable shaft complies with the specification.The introducer sheath used in the intervention was not returned for analysis.Review of the product release 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.The findings of the technical investigation indicate a sequence of unfavorable events which cannot be fully reconstructed.However, the condition of the inner shaft is indicative for the application of a high tensile force despite meeting resistance during device withdrawal.The root cause for the complaint event is therefore most likely related to the handling during the procedure.Please note that the ifu advises the user to exercise care during handling to reduce the possibility of accidental breakage, bending or kinking of the delivery system shaft.

• Brand Name: PULSAR-18 T3 5/40/135
• 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: 17363856
• Report Number: 1028232-2023-03628
• Device Sequence Number: 6042026
• Product Code: NIP
• UDI-Device Identifier: 07640130446878
• UDI-Public: (01)07640130446878(17)2602
• 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): 08/28/2023

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: 02/13/2026
• Device Model Number: 430489
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 01235770
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2023
• Supplement Date Received by Manufacturer: 08/24/2023
• Initial Report FDA Received Date: 07/20/2023
• Supplement Report FDA Received Date: 08/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2023
• 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