MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PULSAR-18 US 4/150/135; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	390709
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
A pulsar-18 peripheral stent system was selected for treatment of a moderately calcified lesion (80 percent stenosis degree) in a mildly tortuous mid sfa.The device was advanced but the stent did not deploy.The device was retrieved, there was no impact to the patient.Another pulsar-18 was introduced and deployed successfully.
Additional Manufacturer Narrative
The returned instrument was subjected to a 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 guidewire used in the intervention was stuck in the guidewire lumen of the affected instrument.The technical investigation revealed that the stent had been pulled in proximal direction together with the retractable shaft.The proximal x-ray markers were pushed against the proximal stent stopper and became deformed, causing a blockage of the retractable shaft.Further, the inner shaft has buckled which is a result of this blockage and in turn caused the blockage of the guidewire.The blockage of the stent is most likely related to uncommonly high friction between the stent and the retractable outer shaft.Review of the production documentation confirmed that the instrument was manufactured according to specifications and passed all in-process and final inspections.Based on the conducted investigations of the device being subject to this complaint, no material or manufacturing related root cause was identified.The final root cause for the complaint event could not be determined.

• Brand Name: PULSAR-18 US 4/150/135
• 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: 12127625
• Report Number: 1028232-2021-03827
• Device Sequence Number: 14309694
• Product Code: NIP
• UDI-Device Identifier: 07640130436466
• UDI-Public: 07640130436466
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P160025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2021

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: 09/30/2022
• Device Model Number: 390709
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 09196343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2021
• Initial Date Received by Manufacturer: 06/22/2021
• Supplement Date Received by Manufacturer: 08/23/2021
• Initial Report FDA Received Date: 07/07/2021
• Supplement Report FDA Received Date: 08/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization