MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PULSAR-18 T3 6/30/90; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	430458
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A pulsar-18 t3 self-expandable stent system was selected for treatment of a small focal stenosis in the left mid common femoral artery proximal to a bypass graft.The pulsar-18 t3 crossed the lesion without issue.During deployment, the stent jumped out of the shaft and migrated distally to the target lesion.Then a longer ptx stent was placed through the pulsar-18 t3 stent for jailing and securing it.The delivery system was confirmed to be less than 25 percent deployed under fluoroscopy.
Additional Manufacturer Narrative
The returned product was subjected to a detailed technical analysis and the corresponding product release documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for this event.In addition, the angiographic material provided was reviewed.The technical investigation revealed that the outer shaft has been fully retracted, and that the stent has been fully released.The shaft dimensions comply with the specification.Inspection of the instrument revealed no damage or irregularity besides a kink in the device shaft at the distal end of the handle lever.The angiographic material provided shows the complaint stent after release located distally to the target lesion.A second stent is then implanted proximally overlapping the complaint stent.The actual complaint event is not visible.The angiographic material does therefore not provide any further relevant information with regards to the root cause of the complaint.Review of the product release documentation confirmed that the device in question was manufactured according to specifications and successfully passed all in-process controls as well as the final inspection.Based on the conducted investigations of the device being subject to this complaint, no material or manufacturing related root cause was determined.Please note that the corresponding ifu advises the user to select an appropriate stent size based on the diameter of the artery adjacent to the lesion.In addition, any slack in the delivery system outside the patient could result in incorrect stent placement, potential stent compression or elongation.Finally, it should be noted that pulsar-18 t3 is indicated for use in patients with atherosclerotic disease of the superficial femoral, proximal popliteal and infrapopliteal arteries and for the treatment of insufficient results after percutaneous transluminal angioplasty (pta), e.G.Residual stenosis and dissection.

• Brand Name: PULSAR-18 T3 6/30/90
• 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: 15887647
• Report Number: 1028232-2022-06084
• Device Sequence Number: 5250342
• Product Code: NIP
• UDI-Device Identifier: 07640130446564
• UDI-Public: (01)07640130446564(17)2506
• 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): 11/28/2022

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 Expiration Date: 06/14/2025
• Device Model Number: 430458
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 05224930
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2022
• Supplement Date Received by Manufacturer: 01/04/2023
• Initial Report FDA Received Date: 11/30/2022
• Supplement Report FDA Received Date: 01/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2022
• 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