MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PULSAR-18 T3 4/30/135; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	430478
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2020
Type of Reportable Event	Malfunction
Event or Problem Description
A pulsar-18 t3 stent system was chosen for treatment in the popliteal artery.The stent released inside the introducer sheath, was withdrawn and not implanted.
Additional Manufacturer Narrative
The returned instrument 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 instrument was located inside a 4f cordis brite tip, 11cm, introducer sheath.The outer shaft of the instrument has been partially retracted and the stent has been partially released.Proximal to the introducer the outer shaft is kinked and compressed at several locations.Outside of the deformed zone the diameter of the outer shaft still complies with the specification.The stent was found severely deformed and fractured at its distal end.The returned introducer is severely deformed at its tip with a minimum inner diameter of 1.47mm.A reference pulsar-18 t3 could be successfully introduced through the returned introducer.Due to the state of the returned instrument, a simulation with a reference introducer sheath was not possible.Review of the production documentation of the product detailed above did not reveal any non-conformity.During final inspection, every stent system undergoes visual inspection for deformations of the outer shaft and the outer diameter is measured over its entire length.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 of the device being subject to this complaint, no material or manufacturing related root cause was determined.It seems likely that the root cause for the complaint event is related to a tolerance issue with the introducer sheath used during the intervention.

• Brand Name: PULSAR-18 T3 4/30/135
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): BIOTRONIK AG, BUELACH, SWITZERLAND; ackerstrasse 6; buelach CH-81 80; CH CH-8180
• MDR Report Key: 11227667
• Report Number: 1028232-2021-00466
• Device Sequence Number: 3512230
• Product Code: NIP
• UDI-Device Identifier: 07640130446762
• UDI-Public: 07640130446762
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2021

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: 10/14/2023
• Device Model Number: 430478
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 10201535
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2021
• Initial Date Received by Manufacturer: 01/25/2021
• Supplement Date Received by Manufacturer: 03/26/2021
• Initial Report FDA Received Date: 01/25/2021
• Supplement Report FDA Received Date: 03/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1