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); Premature Activation (1484)
Health Effect - Clinical Codes	Insufficient Information (4580); 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.The device got stuck inside the 4f introducer sheath and it was impossible to move forward.The distal part broke and the stent self-expanded inside the introducer sheath.The device was retrieved together with the introducer sheath.
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 that the distal portion of the retractable shaft is severely deformed (i.E.Kinked and compressed) over a length of about 30 mm.Outside of the deformed zone, the retractable shaft diameter complies with the specification.The inner shaft is plastically deformed, has fractured, and separated from the system.The inner shaft fragment has a length of about 138 mm.The device tip shows scratch marks and indentations.The inner shaft diameter does not comply anymore with the specification.The stent has been partially released inside the introducer sheath and was also returned fractured.The returned stent fragment is severely deformed at one end and has a length of about 27 mm.The introducer sheath used in the intervention was not returned.Review of the production documentation confirmed that the device was manufactured according to specifications and successfully passed all inprocess controls as well as the final inspection.During final inspection, the retractable shaft of every stent system undergoes visual inspection and a 100 percent control of the retractable shaft diameter is performed.Based on the conducted investigations of the device being subject to this complaint, no material or manufacturing related root cause could be determined.The stent was partially released inside the introducer sheath most likely upon pushing despite meeting resistance.The stent and the inner shaft got stuck and then fractured during the withdrawal attempt due to application of high tensile force.It should be noted that, according to the ifu, the user is advised to exercise care during handling to reduce the possibility of deploying the stent prematurely, accidental breakage, bending or kinking of the delivery system shaft.

• 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: 20944863
• Report Number: 1028232-2024-06461
• Device Sequence Number: 8053868
• Product Code: NIP
• UDI-Device Identifier: 07640130446977
• UDI-Public: (01)07640130446977(17)2707
• 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): 01/13/2025

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: 06244625
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2024
• Supplement Date Received by Manufacturer: 01/10/2025
• Initial Report FDA Received Date: 12/16/2024
• Supplement Report FDA Received Date: 01/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/12/2024
• 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