MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PULSAR-18 7/60/135; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number 377494

Device Problem Activation Failure (3270)

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

Event Date 09/20/2023

Event Type  malfunction  

Event Description

A pulsar-18 self-expandable stent system was selected for treatment of a severely calcified lesion (70 percent stenosis degree) within the severely tortuous mid sfa.The stent could not be released, despite removing the safety tab and pushing the trigger.

Manufacturer Narrative

The returned product 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process could be the cause for the reported event.The technical investigation showed that the outer shaft has not been retracted.The stent has not been released.The outer shaft is kinked at several locations over the entire stent area.The device shaft is further kinked twice at the kink protector, and the proximal portion of the inner shaft is deformed.During the investigation, the handle was opened which revealed that the outer shaft but has fractured inside the handle.The findings indicate that the stent was blocked and pulled against the proximal stent stopper when the outer shaft was retracted.The blockage of the stent was most likely related to uncommonly high friction between the stent and the retractable outer shaft.The kinks in the stent area have probably contributed to the complaint event.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 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 7/60/135
• 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: 17871122
• MDR Text Key: 324926793
• Report Number: 1028232-2023-05030
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 07640130430600
• UDI-Public: (01)07640130430600(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: 11/27/2023

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
• Device Operator: Health Professional
• Device Model Number: 377494
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 02231163
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/04/2023
• Initial Date FDA Received: 10/04/2023
• Supplement Dates Manufacturer Received: 11/21/2023
• Supplement Dates FDA Received: 11/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/16/2023
• 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