MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PULSAR-18 5/60/135; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number 377484

Device Problem Malposition of Device (2616)

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

Event Date 10/25/2023

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) in the moderately tortuous ostial sfa.The device was introduced, and the stent attempted to be released according to the release procedure, but the stent suddenly jumped forward, exceeding the lesion by about 2cm, resulting in the stent failing to cover the lesion completely.Therefore, another stent model was adapted to continue treatment, and the patient had no discomfort after intervention.

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for the reported event.The technical investigation confirmed that the stent has been fully released.The outer shaft has been retracted by about 84 mm.The shaft is kinked at the kink protector.Stent imprints are visible over a length of about 60 mm, indicating that the stent was properly crimped under the outer shaft at the time of delivery.All dimensions of all parts are within specification.When pushing the trigger at the handle the outer shaft is normally retracted.Review of the production documentation confirmed that the product was manufactured according to specifications and passed all in-process and final inspections.Based on the conducted investigations of the device being subject to this complaint, no material or manufacturing related root cause was determined.

• Brand Name: PULSAR-18 5/60/135
• 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: 18096674
• MDR Text Key: 327717788
• Report Number: 1028232-2023-05735
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 07640130430501
• UDI-Public: (01)07640130430501(17)2407
• 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: 12/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 377484
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 07211314
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2021
• 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