MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PULSAR-18 US 7/150/135; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	390739
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
A pulsar-18 peripheral stent system was selected for treatment.After deployment upon post-dilatation with a 6mm balloon at low pressure, the stent fractured and separated into two parts.Another stent was implanted to cover both parts and adapt them to the vessel wall.
Additional Manufacturer Narrative
Neither the complaint instrument nor the angiographic material was provided for analysis.Therefore, no technical investigation on the subject could be performed.The production documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.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 determined.

• Brand Name: PULSAR-18 US 7/150/135
• 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: 11737882
• Report Number: 1028232-2021-02154
• Device Sequence Number: 4092255
• Product Code: NIP
• UDI-Device Identifier: 07640130436763
• UDI-Public: 07640130436763
• 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): 04/16/2021

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: 10/31/2023
• Device Model Number: 390739
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 11201950
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/16/2021
• Supplement Date Received by Manufacturer: 06/15/2021
• Initial Report FDA Received Date: 04/28/2021
• Supplement Report FDA Received Date: 06/16/2021
• 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