MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PULSAR-18 T3 4/100/90; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	430442
Medical Device Problem Codes	Fracture (1260); Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A pulsar-18 t3 peripheral self-expandable stent system was selected for treatment of a severely calcified lesion (stenosis degree: 90 percent) in the mildly tortuous ostial anterior tibial artery.The ostial and more distal lesions were predilated.Then the pulsar-18 t3 was advanced down the wire, but it could not cross the lesion, since it met significant resistance.The pulsar-18 t3 was removed without unlocking the handle.Additional pre-dilatation was performed.During removal of the balloon dilatation catheter, resistance at the hub of the introducer sheath was felt, and it was noticed that the pulsar-18 t3 stent was pulling out.The balloon, sheath and the stent were removed from the patient.All the parts of the pulsar-18 t3 catheter were checked and were intact.The pulsar-18 t3 did not have any parts missing or broken except the stent was not in the undeployed catheter.Balloon dilatation of the lesion was performed, and the patient was discharged without further incident.
Additional Manufacturer Narrative
The complaint device was not returned for analysis.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, the provided images of the device and from the angiogram were reviewed.The two photographs of the device show that the safety button at the handle is not pressed down which is in line with the physicians event description.The outer shaft shows severe deformations (i.E., compression marks) distal to the stabilizer shaft.These compression marks are an indication for forceful pushing against resistance.The stent is fully released, and a small section has fractured, the second fragment is not visible.The distal end of the affected device is not shown in the provided images.The six photographs of the angiogram show parts of the treated vessel as well as the complaint device during the advancement and at the point where resistance was felt.In these images, the stent is still fully crimped underneath the retractable shaft.During the crossing attempt, the retractable shaft appears shifted proximally, but still distal to the stent.No images during the withdrawal were provided.Review of the production documentation confirmed that the device was manufactured according to specifications and successfully passed all inprocess controls as well as the final inspection.During final inspection, the retractable shaft of every stent system undergoes visual inspection, and a 100 percent control of the retractable shaft outer diameter is performed.Based on the conducted investigations of the device being subject to this complaint, no material or manufacturing related root cause could be determined.

• Brand Name: PULSAR-18 T3 4/100/90
• 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: 20024467
• Report Number: 1028232-2024-04368
• Device Sequence Number: 7476896
• Product Code: NIP
• UDI-Device Identifier: 07640130446403
• UDI-Public: (01)07640130446403(17)2704
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: P160025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2024

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: 430442
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 04240902
• 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: 08/15/2024
• Supplement Date Received by Manufacturer: 09/16/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 09/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2024
• 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