MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PULSAR-18 T3 5/200/135; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	430496
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The pulsar-18 t3 peripheral self-expandable stent was implanted on (b)(6) 2024.Approximately 7 weeks later the patient returned on (b)(6) 2024 with recurring symptoms.Upon fluoroscopic exam the vessel was noted to be renarrowed and the stent fractured into type 3 stent fractures and was noted to be separated into 3 pieces, with areas of type 1 also evident.Another stent was placed on (b)(6) 2024 and this pulsar remained implanted.
Additional Manufacturer Narrative
Neither the affected device nor the angiographic material was returned.Instead, two photographs taken from the angiogram were provided.The production documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.The photographs taken from the angiogram show the target vessel with numerous narrowed zones about eight weeks after the initial procedure.The stent has fractured into three pieces.Geometric distortions of the stent structure are visible.Unfortunately, no angiographic material of the baseline procedure could be obtained.The photographs provided do not contain further relevant information regarding the root cause of the reported event.Review of the production documentation confirmed that the device was manufactured according to specifications and passed all in-process and final inspections.Based on the conducted investigations, no material or manufacturing related root cause could be determined.Please note that, according to the ifu, fractures of nitinol stents implanted in the superficial femoral artery have been reported in medical literature.Fractures occurred more frequently and were more severe in long stented segments and in the case of multiple, partially overlapping stents.These fractures were frequently associated with restenosis or occlusion of the artery.

• Brand Name: PULSAR-18 T3 5/200/135
• 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: 20258518
• Report Number: 1028232-2024-04941
• Device Sequence Number: 7742763
• Product Code: NIP
• UDI-Device Identifier: 07640130446946
• UDI-Public: (01)07640130446946(17)2702
• 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: 2024
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2024

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 Model Number: 430496
• Device Catalogue Number: 430496
• Device Lot Number: 01243388
• 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: 09/03/2024
• Supplement Date Received by Manufacturer: 11/01/2024
• Initial Report FDA Received Date: 09/19/2024
• Supplement Report FDA Received Date: 11/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2024
• 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 Age: 64 YR
• Patient Sex: Male