MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PULSAR-18 5/170/135; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number 366836

Device Problem Activation Failure (3270)

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

Event Date 11/12/2021

Event Type  malfunction  

Event Description

A pulsar-18 peripheral stent system was selected for treatment of a mildly calcified lesion (70 percent stenosis degree) in a moderately tortuous mid femoral artery.After placing the device in the lesion, the trigger did not work.Subsequently, the secondary release was used but did not work either.The stent did not release but moved backward with the outer sheath.Guide wire and device were removed together, and another pulsar-18 was used successfully.

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process could be the cause for the reported event.The technical investigation revealed that the outer shaft has been retracted by 9.5 mm.The stent is still crimped under the outer shaft and has not been released.The outer shaft is kinked at several locations and deformed (i.E.Constricted) over a length of about 3 mm.Outside of the deformed zone the outer shaft diameter complies with the specification.Inside the handle the outer shaft was found fractured most likely occurred due to tensile overload.Also, the proximal end of the inner shaft is deformed (i.E.Compressed).The findings indicate that the outer shaft was blocked during pullback which could be related to uncommonly high friction between the stent and the outer shaft.Review of the production documentation confirmed that the instrument was manufactured according the specifications and passed all inprocess and final inspections.Based on the conducted investigations of the device being subject to this complaint, no material or manufacturing related root cause could be identified.The final root cause for the reported event could not be determined.It should be noted that the ifu advices to remove the complete system from the patient if the trigger release mechanism fails before releasing the stent.

• Brand Name: PULSAR-18 5/170/135
• 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: 12860255
• MDR Text Key: 281137701
• Report Number: 1028232-2021-06370
• Device Sequence Number: 1
• Product Code: NIP
• 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: 11/22/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 03/13/2024
• Device Model Number: 366836
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 03211948
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/22/2021
• Initial Date FDA Received: 11/23/2021
• Supplement Dates Manufacturer Received: 02/16/2022
• Supplement Dates FDA Received: 02/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/16/2021
• 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