MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PULSAR-18 T3 6/40/135; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	430499
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A pulsar-18 t3 self-expandable stent system was selected for treatment of a predilated lesion with 80 percent stenosis degree in the popliteal artery.After the pulsar-18 t3 was deployed, it was noticed that the stent was deformed at the distal end.Post-dilatation was performed.The stent remains in patient.Patient was discharged home.
Additional Manufacturer Narrative
The affected product was not returned.Therefore, no technical investigation on the subject could be performed.The production documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.In addition, two videos and six photographs taken from the angiogram were reviewed.The videos and photographs provided show the stenosed popliteal artery with the stent after its release.Geometric distortions of the stent structure are visible.The inhomogeneous radiopacity in the distal stent portion may be suggestive of a focal stent compression.However, the quality of both the videos and the photographs is rather poor.Review of the production documentation confirmed that the device was manufactured according to specifications and fulfilled all the requirements of in-process and final inspection.Based on the conducted investigations of the device being subject to this complaint, no material or manufacturing related root cause could be determined.Please note that, according to the ifu, 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 6/40/135
• 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: 18004683
• Report Number: 1028232-2023-05420
• Device Sequence Number: 18037866
• Product Code: NIP
• UDI-Device Identifier: 07640130446977
• UDI-Public: (01)07640130446977(17)2606
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P160025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2023

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: 06/14/2026
• Device Model Number: 430499
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 05233277
• 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: 10/10/2023
• Supplement Date Received by Manufacturer: 12/06/2023
• Initial Report FDA Received Date: 10/25/2023
• Supplement Report FDA Received Date: 12/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2023
• 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: Hospitalization
• Patient Sex: Unknown