MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PULSAR-18 7/40/135; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number 377493

Device Problem Activation Failure (3270)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/18/2023

Event Type  malfunction  

Event Description

A pulsar-18 self-expandable stent system was selected for treatment of the moderately tortuous sfa.It was not possible to release the stent in the moderately calcified lesion.

Manufacturer Narrative

The returned product 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process could be the cause for the reported event.The technical investigation revealed that the outer shaft has been retracted by about 6 mm.The stent has not been released.The outer shaft has buckled at the proximal radiopaque marker and about 13 mm proximal to this marker.Also, the device shaft is kinked about 554 mm proximal to its distal end, and the proximal portion of the inner shaft is compressed.The handle was returned open and completely disassembled with a part of the assembly missing.In general, the findings indicate that the stent was blocked and pulled back against the proximal stent stopper when the outer shaft was retracted.The blockage of the stent was most likely related to uncommonly high friction between the stent and the retractable outer shaft.Review of the production documentation verified that the instrument was manufactured according to specifications and fulfilled all the requirements of in-process and final inspection.Based on the conducted investigations, no material or manufacturing related root cause was identified.The final root cause for the reported event could not be determined.It should be noted that the ifu advises the user to only open the handle in the case that the trigger release mechanism fails with partial release of the stent.

• Brand Name: PULSAR-18 7/40/135
• Type of Device: 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: 17862210
• MDR Text Key: 324821607
• Report Number: 1028232-2023-05007
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 07640130430594
• UDI-Public: (01)07640130430594(17)2602
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P160025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 377493
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 02231162
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/14/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1