MAUDE Adverse Event Report: BIOTRONIK AG PULSAR-18 T3 4/40/135; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	430479
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/13/2025
Type of Reportable Event	Malfunction
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.In addition, the still images from the angiogram provided were reviewed.The still images of the angiogram show clearly the separated tip in the forefoot of the patient.However, the fracture of the affected device during the procedure is not shown.The affected device was returned for investigation.The outer shaft has been partially retracted and the stent partially released.The device inner shaft has fractured directly proximal to the tip.A visible spiral-shaped cut has been detected at the fracture site, which has most likely been induced during the fabrication of the suppliers component.The dimensions of the shaft components comply with the specification.The stent could be fully released during investigation.The handle is undamaged and shows no irregularities.The root cause for the reported event is most likely related to the manufacturing process of a component produced by a supplier.The relevant internal departments were informed about the investigation results.The supplier of the affected component was informed and acknowledged the complaint.It should be noted that the pulsar-18 t3 is indicated for use in patients with atherosclerotic disease of the superficial femoral, proximal popliteal and infrapopliteal arteries.
Event or Problem Description
The pulsar-18 t3 peripheral self-expandable stent system was selected for treatment of a moderately calcified lesion (85 percent stenosis degree) in the moderately tortuous mid popliteal artery.During the procedure, before releasing the stent, it was noticed that the tip had separated from the delivery system.The separated tip was decided to be left in the patient.No issues with blood flow so far.The procedure was completed by using another pulsar-18 t3.After additional communication with the local staff, it could be confirmed that the stent was partially released outside of the patient after withdrawal to confirm that only the tip of the device remained in the patient.
Event or Problem Description
The pulsar-18 t3 peripheral self-expandable stent system was selected for treatment of a moderately calcified lesion (85 percent stenosis degree) in the moderately tortuous mid popliteal artery.During the procedure, before releasing the stent, it was noticed that the tip had separated from the delivery system.The separated tip was decided to be left in the patient.No issues with blood flow so far.The procedure was completed by using another pulsar-18 t3.After additional communication with the local staff, it could be confirmed that the stent was partially released outside of the patient after withdrawal to confirm that only the tip of the device remained in the patient.
Additional Manufacturer Narrative
Please note that the initial report was submitted by biotronik, inc.(cfn/fei (b)(4)).The final report was submitted by biotronik ag (cfn (b)(4)).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.In addition, the still images from the angiogram provided were reviewed.The still images of the angiogram show clearly the separated tip in the forefoot of the patient.However, the fracture of the affected device during the procedure is not shown.The affected device was returned for investigation.The outer shaft has been partially retracted and the stent partially released.The device inner shaft has fractured directly proximal to the tip.A visible spiral-shaped cut has been detected at the fracture site, which has most likely been induced during the fabrication of the supplier's component.The dimensions of the shaft components comply with the specification.The stent could be fully released during investigation.The handle is undamaged and shows no irregularities.The root cause for the reported event is most likely related to the manufacturing process of a component produced by a supplier.The relevant internal departments were informed about the investigation results.The supplier of the affected component was informed and acknowledged the complaint.It should be noted that the pulsar-18 t3 is indicated for use in patients with atherosclerotic disease of the superficial femoral, proximal popliteal and infrapopliteal arteries.Additional information after investigation: the issue triggered a corrective action in which the supplier identified the most probable root cause as an operator error.During removal of excess overmould material, use of a blade caused cuts in the outer surface of the inner shaft which eventually favored the detachment of the tip during the intervention.To prevent recurrence the corresponding work instructions were updated and operators retrained.The effectiveness of the corrective action was verified, and since its implementation, no further complaints with the same root cause have been received.

• Brand Name: PULSAR-18 T3 4/40/135
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): 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: 21710980
• Report Number: 1028232-2025-01520
• Device Sequence Number: 17271892
• Product Code: NIP
• UDI-Device Identifier: 07640130446779
• UDI-Public: (01)07640130446779(17)271006(10)09243434
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2025

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: 430479
• Device Catalogue Number: 430479
• Device Lot Number: 09243434
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/27/2025
• Supplement Report FDA Received Date: 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2024
• 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