MAUDE Adverse Event Report: BIOTRONIK AG PULSAR-18 T3 6/150/135; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	430504
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The pulsar-18 t3 peripheral self-expandable stent system was selected for treatment of a mildly calcified lesion (75% stenosis degree) in a lower extremity artery.After pre-dilatation and before stent placement, a metallic object was observed moving within the vessel.After successful deployment of the stent, the delivery system was withdrawn.It was then discovered that the tip of the delivery system was missing.Multiple retrieval attempts were made to recover the detached tip, but these were unsuccessful.The tip migrated distally within the leg vessel.Due to the patient's unstable condition, surgical removal via vessel incision was considered but ultimately not performed.The procedure was halted to avoid further risk to the patient.
Event or Problem Description
The pulsar-18 t3 peripheral self-expandable stent system was selected for treatment of a mildly calcified lesion (75% stenosis degree) in a lower extremity artery.After pre-dilatation and before stent placement, a metallic object was observed moving within the vessel.After successful deployment of the stent, the delivery system was withdrawn.It was then discovered that the tip of the delivery system was missing.Multiple retrieval attempts were made to recover the detached tip, but these were unsuccessful.The tip migrated distally within the leg vessel.Due to the patient's unstable condition, surgical removal via vessel incision was considered but ultimately not performed.The procedure was halted to avoid further risk to the patient.
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 video and the still image from the angiogram provided were reviewed.The video and the still image of the angiogram show clearly the separated tip in the lower limb 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 completely retracted and the stent was fully released as reported.The device inner shaft has fractured directly proximal to the tip.The fracture surface is orthogonal to the shaft axis.The surface of the fracture site is widely damaged by secondary mechanical deformation, which makes it impossible to determine more information about the possible root cause for the complaint event.The dimensions of the shaft components comply with the specification.The handle is undamaged and shows no irregularities.Based on the conducted investigations of the device being subject to this complaint, no material or manufacturing related root cause could be identified.The final root cause for the reported event could not be determined.

• Brand Name: PULSAR-18 T3 6/150/135
• 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 8180 ; SZ 8180
• MDR Report Key: 22825723
• Report Number: 8043892-2025-07282
• Device Sequence Number: 9566893
• Product Code: NIP
• UDI-Device Identifier: 07640130447028
• UDI-Public: (01)07640130447028(17)280310(10)02254809
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 430504
• Device Lot Number: 02254809
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2025
• Supplement Date Received by Manufacturer: 07/28/2025
• Initial Report FDA Received Date: 08/18/2025
• Supplement Report FDA Received Date: 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2025
• 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: Required Intervention
• Patient Sex: Unknown