MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PULSAR-18 5/150/135; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number 366835

Device Problems Fracture (1260); Activation Failure (3270)

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

Event Date 04/14/2023

Event Type  malfunction  

Event Description

A pulsar-18 self-expandable stent system was selected for treatment.A very long lesion in the sfa was treated with two pulsar-18 stents.The 1st one was successfully implanted.The 2nd stent was introduced but could only be partially released.The physician unpacked the trigger, but the delivery catheter (blue shaft) was already found fractured.It was decided to remove the 2nd stent system.But the partially released stent was covered with the first stent, so the first stent was also fractured during withdrawal, and the location of the 1st stent moved to ostial.After several attempts the physician successfully withdrew the whole system.Three other stents were implanted in the lesion.The patient was stable and discharged home.

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.In addition, six photographs taken from the angiogram were reviewed.The instrument was returned completely disassembled.The outer shaft has been retracted by about 26 mm, and that the stent has been partially released.The stent is elongated and has fractured at its distal end.In addition, both the inner and outer shaft have fractured.The proximal stent stopper and the proximal end of the inner shaft show signs of compression.Reassembling of the handle showed that no parts are damaged or 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findings indicate that the stent was blocked and pulled back against the proximal stent stopper when the outer shaft was retracted.The blockage of the stent was most likely related to uncommonly high friction between the stent and the retractable outer shaft.The photographs taken from the angiogram did not provide further relevant information regarding the root cause of the complaint.The photographs show a stent fragment in the sfa.Also, numerous stents implanted in the sfa are shown.Geometric distortions of the stent structure of the most proximal stent are visible.The inhomogeneous radiopacity along the stent length may be suggestive of a stent compression.Review of the production documentation confirmed that the device 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.

• Brand Name: PULSAR-18 5/150/135
• 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: 16936587
• MDR Text Key: 315269894
• Report Number: 1028232-2023-02458
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 07640130415096
• UDI-Public: (01)07640130415096(17)2501
• 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: 07/12/2023

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: 366835
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 12215390
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/12/2023
• Initial Date FDA Received: 05/15/2023
• Supplement Dates Manufacturer Received: 07/12/2023
• Supplement Dates FDA Received: 07/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2022
• 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