MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PULSAR-18 T3 6/60/90; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	430460
Medical Device Problem Codes	Fracture (1260); Activation Failure (3270)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A pulsar-18 t3 self-expandable stent system was selected for a treatment in the distal popliteal artery with a stenosis degree of 100 percent.During treatment approximately 1cm of the stent was released.The deployment wheel knob was fully rotated, but the stent did not open.The partially opened stent was pulled out with the introducer.The opened part of the stent got stuck at the arterial entry point and the stent was disrupted.The small detached part of the stent was removed surgically.
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 angiographic material provided was reviewed.The angiographic material shows the treatment of the total occlusion in the popliteal artery.Eventually, a stent fragment can be seen at the distal portion of the introducer sheath used in the intervention.However, the partial stent release as described and the withdrawal of the affected device are not shown.The actual complaint event is not visible, and the angiographic material does not provide further relevant information with regards to the root cause of the reported event.The affected device was returned with the 0.018 inch guidewire used in the intervention located inside the guidewire lumen.The outer shaft has been retracted by about 37 mm.The device shafts show no damage or irregularity.The dimensions of the shaft components comply with the specification.The stent has been released and was returned fractured in two parts.Both stent fragments show severe deformations.It can not be fully excluded that during the attempt to retract the device into the introducer, the stent possibly experienced higher force.The handle was returned opened and partially disassembled.The rotating wheel can be normally rotated.Dissection of the device revealed that the gluing between the retractable shaft and the metal tube which is welded onto the pull-wire has failed.The root cause for the reported event is most likely related to a component produced by a supplier.The relevant internal departments and the supplier were informed about the investigation results.
Additional Manufacturer Narrative
Corrected the initial reporter information.Reference (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 angiographic material provided was reviewed.The angiographic material shows the treatment of the total occlusion in the popliteal artery.Eventually, a stent fragment can be seen at the distal portion of the introducer sheath used in the intervention.However, the partial stent release as described and the withdrawal of the affected device are not shown.The actual complaint event is not visible, and the angiographic material does not provide further relevant information with regards to the root cause of the reported event.The affected device was returned with the 0.018 inch guidewire used in the intervention located inside the guidewire lumen.The outer shaft has been retracted by about 37 mm.The device shafts show no damage or irregularity.The dimensions of the shaft components comply with the specification.The stent has been released and was returned fractured in two parts.Both stent fragments show severe deformations.It can not be fully excluded that during the attempt to retract the device into the introducer, the stent possibly experienced higher force.The handle was returned opened and partially disassembled.The rotating wheel can be normally rotated.Dissection of the device revealed that the gluing between the retractable shaft and the metal tube which is welded onto the pull-wire has failed.The root cause for the reported event is most likely related to a component produced by a supplier.The relevant internal departments and the supplier were informed about the investigation results.
Event or Problem Description
A pulsar-18 t3 self-expandable stent system was selected for a treatment in the distal popliteal artery with a stenosis degree of 100 percent.During treatment approximately 1cm of the stent was released.The deployment wheel knob was fully rotated, but the stent did not open.The partially opened stent was pulled out with the introducer.The opened part of the stent got stuck at the arterial entry point and the stent was disrupted.The small detached part of the stent was removed surgically.
Additional Manufacturer Narrative
Corrected the initial reporter information.Reference capa# (b)(4).The technical investigation revealed that the gluing between the retractable shaft and the bushing (i.E.The metal tube which is welded onto the pull-wire) has failed.The respective component is produced by a supplier.Internal departments have been informed and to prevent recurrence, it was decided that technical drawings were adjusted by freudenberg medical.Fmds were updated.The corrective action has been successfully closed.

• Brand Name: PULSAR-18 T3 6/60/90
• 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: 19315645
• Report Number: 1028232-2024-02648
• Device Sequence Number: 7010588
• Product Code: NIP
• UDI-Device Identifier: 07640130446588
• UDI-Public: (01)07640130446588(17)2610
• Combination Product (Y/N): N
• Initial Reporter Country: HU
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/12/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/04/2026
• Device Model Number: 430460
• Device Catalogue Number: 430460
• Device Lot Number: 09234550
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2024
• Supplement Date Received by Manufacturer: 08/05/2024; 11/05/2024; 05/12/2025
• Initial Report FDA Received Date: 05/14/2024
• Supplement Report FDA Received Date: 08/05/2024; 11/05/2024; 05/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/06/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown