MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PULSAR-18 T3 6/80/135; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	430501
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A pulsar-18 t3 stent system was chosen for treatment of a severely calcified lesion (80 percent stenosis degree) in the moderately tortuous proximal sfa.After predilatation one pulsar-18 t3 was implanted, another dilatation with a passeo-18 lux was performed and then a second pulsar-18 t3 (complaint device) was implanted.During withdrawal resistance was felt.It was detected that ca.15 cm of the shaft fractured and remained on the delivery system.All parts could be retrieved.
Additional Manufacturer Narrative
The returned instrument was subjected to a detailed technical analysis and the corresponding product release documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.The technical investigation revealed that the inner shaft has fractured and separated from the rest of the system.The separated inner shaft fragment has a length of about 527 mm.The fragment is severely elongated and the fracture site is plastically deformed, both indicating application of a high tensile force.The stabilizer shaft shows severe compression marks, particularly at the transition to the handle lever.This finding implies that the retractable shaft has been pulled too far back after stent release.Moreover, the retractable shaft shows signs of compression in its distal portion, indicating application of a pushing force despite meeting resistance.The exact sequence of these events cannot be reconstructed.The introducer sheath and the guidewire used in the intervention were not returned for analysis.Review of the product release documentation confirmed that the device in question was manufactured according to specifications and successfully passed all in-process controls as well as the final inspection.Based on the conducted investigations, no material or manufacturing related root cause was determined.The root cause for the complaint event is most likely related to the handling during the procedure.Please note that the ifu advises the user to exercise care during handling to reduce the possibility of accidental breakage of the delivery system shaft.

• Brand Name: PULSAR-18 T3 6/80/135
• 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: 15250794
• Report Number: 1028232-2022-04221
• Device Sequence Number: 6493493
• Product Code: NIP
• UDI-Device Identifier: 07640130446991
• UDI-Public: (01)07640130446991(17)2505
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 08/18/2022

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: 05/18/2025
• Device Model Number: 430501
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 04221560
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2022
• Supplement Date Received by Manufacturer: 10/19/2022
• Initial Report FDA Received Date: 08/18/2022
• Supplement Report FDA Received Date: 10/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/30/2022
• 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
• Patient Sex: Unknown