MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PULSAR-18 T3 7/200/135; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	430516
Medical Device Problem Code	Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A pulsar-18 self-expandable stent system was selected for treatment.The ratchet release wheel stopped prior to releasing the entire 200mm stent.The operator was able to get the stent off the delivery system and used a pta balloon and stent to complete the case.The stent remained in the vessel as planned.
Additional Manufacturer Narrative
After additional correspondence with the local staff, the physician described that he felt that the wheel had rotated and stopped normally.He began retracting the catheter back towards the sheath and noticed resistance.Under fluoroscopy he determined that the stent had not been released.The physician then resumed retracting the deployment catheter at which time the stent released.After post-militating, the stent was determined to be in an acceptable position.The patient was discharged without incident.The physician could not confirm if the restraining catheter was fully retracted with the stent still attached but he believes it was.Investigation results: 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 the reported event.In the as-returned state, the distal end of the retractable shaft was located about 21 mm proximal to the distal end of the stopper shaft.The stent has been released in the patients body and was thus not returned.The retractable shaft was found mildly deformed (i.E.Flared) at its distal end.Inspection of the remainder of the device revealed no other damage or irregularity.Outside of the deformed zone, the dimensions of the device components comply with the specification.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.
Additional Manufacturer Narrative
Corrected the initial reporter information.Reference capa# nc-24-004.Additional event description: after additional correspondence with the local staff, the physician described that he felt that the wheel had rotated and stopped normally.He began retracting the catheter back towards the sheath and noticed resistance.Under fluoroscopy he determined that the stent had not been released.The physician then resumed retracting the deployment catheter at which time the stent released.After post-militating, the stent was determined to be in an acceptable position.The patient was discharged without incident.The physician could not confirm if the restraining catheter was fully retracted with the stent still attached but he believes it was.Investigation results: 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 the reported event.In the as-returned state, the distal end of the retractable shaft was located about 21 mm proximal to the distal end of the stopper shaft.The stent has been released in the patients body and was thus not returned.The retractable shaft was found mildly deformed (i.E.Flared) at its distal end.Inspection of the remainder of the device revealed no other damage or irregularity.Outside of the deformed zone, the dimensions of the device components comply with the specification.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.

• Brand Name: PULSAR-18 T3 7/200/135
• 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: 18737812
• Report Number: 1028232-2024-00949
• Device Sequence Number: 12573401
• Product Code: NIP
• UDI-Device Identifier: 07640130447141
• UDI-Public: (01)07640130447141(17)2609
• 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
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/21/2024

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 Expiration Date: 09/12/2026
• Device Model Number: 430516
• Device Catalogue Number: 430516
• Device Lot Number: 09230341
• 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: 02/07/2024
• Supplement Date Received by Manufacturer: 04/09/2024; 10/21/2024
• Initial Report FDA Received Date: 02/20/2024
• Supplement Report FDA Received Date: 04/09/2024; 10/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/14/2023
• 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