MAUDE Adverse Event Report: BIOTRONIK AG PULSAR-18 T3 5/100/135; STENT, SUPERFICIAL FEMORAL ARTERY,

Model Number	430492
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The pulsar-18 t3 peripheral self-expandable stent system was selected for treatment of a mildly calcified lesion in a mildly tortuous part of the sfa.The stent could not be released.The wheel on the release device turned without stopping and did not release the stent as intended.The system was removed, and another stent was implanted.
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process could be the cause for the reported event.The technical investigation confirmed that the outer shaft has not been retracted.Consequently, the stent has not been released.During the investigation, the device was dissected which revealed that the gluing between the retractable outer shaft and the metal tube which is welded onto the pull-wire has failed.The most probable root cause for the reported event is related to the manufacturing process of a component produced by a supplier.To prevent recurrence the respective internal departments were informed about this case.The supplier of the affected component was informed and acknowledged the complaint.
Event or Problem Description
The pulsar-18 t3 peripheral self-expandable stent system was selected for treatment of a mildly calcified lesion in a mildly tortuous part of the sfa.The stent could not be released.The wheel on the release device turned without stopping and did not release the stent as intended.The system was removed, and another stent was implanted.
Additional Manufacturer Narrative
Please note that the initial report was submitted by biotronik, inc.(cfn/fei 1028232).The final report was submitted by biotronik ag (cfn 8043892, fei 3002808050).Complaint investigation: 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process could be the cause for the reported event.The technical investigation confirmed that the outer shaft has not been retracted.Consequently, the stent has not been released.During the investigation, the device was dissected which revealed that the gluing between the retractable outer shaft and the metal tube which is welded onto the pull-wire has failed.The most probable root cause for the reported event is related to the manufacturing process of a component produced by a supplier.To prevent recurrence the respective internal departments were informed about this case.The supplier of the affected component was informed and acknowledged the complaint.After capa closure: the issue triggered a corrective action in which the manufacturing process of a subassembly produced by the supplier was identified as root cause.Microscopic inspection showed that the adhesive has not well spread and only covers approx.1/3 of the actual bonding area.This was confirmed by ftir analysis.An additional root cause analysis was also performed by the supplier vistamed ltd.T/a freudenberg medical.To prevent recurrence, technical drawings were adjusted by freudenberg medical.
Event or Problem Description
It was reported that the icd sn (b)(6) was not interrogable anymore.An update from october 25, 2024, indicated that this lead was the predecessor lead to sn (b)(6).It was capped in 2016 due to malfunctioning at that time and is now also extracted effective (b)(6) 2024.

• Brand Name: PULSAR-18 T3 5/100/135
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY,
• Manufacturer (Section D): BIOTRONIK AG; ackerstrasse 6; bulach, zurich 8180 ; SZ 8180
• Manufacturer (Section G): BIOTRONIK AG; ackerstrasse 6; bulach, zurich 8180 ; SZ 8180
• Manufacturer Contact: ramona ergler ; ackerstrasse 6; bulach, zurich, OR 8180 ; SZ 8180 ; 8772459800
• MDR Report Key: 21527460
• Report Number: 1028232-2025-01146
• Device Sequence Number: 13166509
• Product Code: NIP
• UDI-Device Identifier: 07640130446908
• UDI-Public: (01)07640130446908(17)271105(10)10242503
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: P160025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/04/2025

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: 430492
• Device Catalogue Number: 430492
• Device Lot Number: 10242503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2025
• Supplement Date Received by Manufacturer: 04/10/2025; 04/10/2025
• Initial Report FDA Received Date: 03/05/2025
• Supplement Report FDA Received Date: 04/10/2025; 11/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2024
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown