MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PULSAR-18 6/60/135; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number 377489

Device Problem Premature Activation (1484)

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

Event Date 10/21/2022

Event Type  malfunction  

Event Description

A pulsar-18 self-expandable stent system was selected for treatment of a moderately calcified lesion (75 percent stenosis degree) in the moderately tortuous mid femoral artery.The stent was delivered to the lesion and after removing the safety tab and pushing the trigger, it was not possible to release the stent.Thus, it was decided to remove the stent system but eventually the stent was found stuck inside the is.Another stent was used to finish the procedure.

Manufacturer Narrative

The returned instrument 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.In addition, a photograph of a guiding catheter was reviewed.The technical investigation revealed that the outer shaft has been retracted by about 515 mm, i.E.The stent has been fully released.The shaft dimensions comply with the specification.Both the outer and inner shaft were found kinked distally at the same location, indicating that the kink was already present before retraction of the outer shaft.It is thus possible that the kink may have contributed to the reported complaint event.Besides, a 6f envoy guiding catheter was returned.The braid material at the distal end of the guiding catheter is severely deformed and has fractured.The distal part of the guiding catheter and the stent were not returned for analysis.The provided photograph shows that the guiding catheter is severely deformed in its distal portion and has fractured in at least two parts.Review of the product release documentation confirmed that the device in question was manufactured according to specifications and successfully passed all in-process controls as well as the final inspection.Based on the conducted investigations of the device being subject to this complaint, no material or manufacturing related root cause could be determined.

• Brand Name: PULSAR-18 6/60/135
• 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: 15801440
• MDR Text Key: 303724124
• Report Number: 1028232-2022-05822
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 07640130430556
• UDI-Public: (01)07640130430556(17)2410
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P170030
• 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: 11/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 377489
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 11212054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2021
• 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