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

Model Number 430458

Device Problem Malposition of Device (2616)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/09/2022

Event Type  malfunction  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 304726454
• Report Number: 1028232-2022-06084
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 07640130446564
• UDI-Public: (01)07640130446564(17)2506
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P160025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 01/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1