MAUDE Adverse Event Report: BIOTRONIK AG PULSAR-18 T3 6/200/90; STENT,

Model Number	430466
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	Pain (1994); Restenosis (4576)
Date of Event	10/14/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The pulsar-18 t3 peripheral self-expandable stent system was selected for treatment and was implanted on (b)(6) 2024 in the moderately tortuous left sfa.On repeat angiogram on (b)(6) 2025 it was noted that previously deployed stent was crushed, and the sfa is totally occluded.The patient is now treated medically.
Additional Manufacturer Narrative
Please note that the initial report was submitted by biotronik, inc.(cfn/fei 1028232).The final report was submitted by biotronik ag (cfn 8043892, fei 3002808050).Neither the affected device nor the angiographic material was 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 images and two videos taken from the angiogram were reviewed.The images show a released stent in the proximal segment of the sfa.Away from the most proximal end, geometric distortions of the stent structure are recognizable.The inhomogeneous radiopacity at the distal end of the stent may be suggestive of focal stent compression or elongation.The videos provided show the proximal sfa.There is no clear visibility of the stent, which is good enough to value the state of the adaptation of the stent inside of the vessel.Unfortunately, the quality of the videos 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, no material or manufacturing related root cause could be determined.
Event or Problem Description
The pulsar-18 t3 peripheral self-expandable stent system was selected for treatment and was implanted on (b)(6) 2024, in the moderately tortuous left sfa.On repeat angiogram on (b)(6) 2025, it was noted that previously deployed stent was crushed, and the sfa is totally occluded.The patient is now treated medically.

• Brand Name: PULSAR-18 T3 6/200/90
• Common Device Name: STENT,
• 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, OR 8180 ; SZ 8180 ; 8772459800
• MDR Report Key: 22285911
• Report Number: 1028232-2025-02940
• Device Sequence Number: 15683896
• Product Code: NIP
• UDI-Device Identifier: 07640130446649
• UDI-Public: (01)07640130446649(17)2511
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P160025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2025

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: 11/05/2025
• Device Model Number: 430466
• Device Catalogue Number: 430466
• Device Lot Number: 10224653
• 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: 06/04/2025
• Supplement Date Received by Manufacturer: 06/05/2025
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 08/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/07/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female