MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PULSAR-18 T3 5/80/135; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	430491
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Codes	Hematoma (1884); Device Embedded In Tissue or Plaque (3165)
Date of Event	01/29/2020
Type of Reportable Event	Malfunction
Event or Problem Description
A pulsar-18 t3 stent system was chosen for treatment of a moderately calcified lesion (100 percent stenosis degree) in a mildly tortuous popliteal artery.The sheath could not be crossed with the device.During withdrawal the stent opened up inside and outside patient.The stent was deliberately cut and 1mm remained in patient.
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.The technical investigation revealed that the distal end of the device has been cut and that a maximum of about 1.2 cm of the inner shaft is missing which is in line with the physicians description.The retractable outer shaft is severely deformed over a length of about 4.5 cm.Outside of the deformed zone the diameter of the retractable outer shaft still complies with the specification.Due to the state of the device a simulation with a reference introducer sheath could not be conducted.The stent was discarded and not returned for analysis.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.

• Brand Name: PULSAR-18 T3 5/80/135
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): BIOTRONIK AG, BUELACH, SWITZERLAND; ackerstrasse 6; buelach CH-81 80; CH CH-8180
• MDR Report Key: 9758264
• Report Number: 1028232-2020-00963
• Device Sequence Number: 2650566
• Product Code: NIP
• UDI-Device Identifier: 07640130446892
• UDI-Public: 07640130446892
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P160025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2020

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: 10/31/2020
• Device Model Number: 430491
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 11191375
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/21/2020
• Supplement Date Received by Manufacturer: 05/15/2020
• Initial Report FDA Received Date: 02/26/2020
• Supplement Report FDA Received Date: 05/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1