MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PULSAR-18 T3 7/60/135; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	430510
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The pulsar-18 t3 peripheral self-expandable stent system was selected for treatment of distal intermural hematoma of the superior mesenteric artery.The device was introduced, but the stent could not be released within the lesion.The device was retrieved.
Event or Problem Description
The pulsar-18 t3 peripheral self-expandable stent system was selected for treatment of distal intermural hematoma of the superior mesenteric artery.The device was introduced, but the stent could not be released within the lesion.The device was retrieved.
Additional Manufacturer Narrative
The returned product was subjected to a detailed technical analysis and the corresponding production documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for this event.Even after additional communication with the local staff, the angiographic material of the procedure could not be obtained.The technical investigation revealed that the stent was fully released and was not returned, the safety button was pressed down.The device shaft shows no damage or irregularity.The dimensions of the shaft system were measured and complies with the specification.The tip of the retractable shaft shows a deformation at its distal end, around the proximal end of the distal radiopaque marker.After flushing, a 0.018 inch reference guidewire could be fully introduced with no unusual resistance.When turning the release wheel, the outer shaft retracts normally.The provided video was reviewed.The withdrawal of the complaint device outside of the patient is shown.After withdrawal, the distal end of the device is shown with the retractable shaft still covering the distal end of the stopper shaft with the proximal radiopaque marker.The stent is not recorded.The provided material does not provide further relevant information regarding the root cause of the complaint.Review of the production documentation confirmed that the device was manufactured according to specifications and passed all in-process and final inspections.During production of the stent, the stent outer diameter is measured to in the fully expanded state to 100 percent.Based on the conducted investigations of the device being subject to this complaint, no material or manufacturing related root cause could be determined.It should be noted that the pulsar-18 t3 is indicated for use in patients with atherosclerotic disease of the superficial femoral, proximal popliteal and infrapopliteal arteries.

• Brand Name: PULSAR-18 T3 7/60/135
• 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: 21213695
• Report Number: 1028232-2025-00371
• Device Sequence Number: 3467414
• Product Code: NIP
• UDI-Device Identifier: 07640130447080
• UDI-Public: (01)07640130447080(17)2708
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: P160025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2025

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: 430510
• Device Catalogue Number: 430510
• Device Lot Number: 07242392
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2025
• Supplement Date Received by Manufacturer: 03/24/2025
• Initial Report FDA Received Date: 01/22/2025
• Supplement Report FDA Received Date: 03/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2024
• 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
• Patient Sex: Unknown