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

Model Number 377484

Device Problem Activation Failure (3270)

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

Event Date 12/22/2023

Event Type  malfunction  

Manufacturer Narrative

Neither the complaint product nor the angiographic material was returned for analysis.Therefore, no technical investigation on the subject could be performed.The production documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.Review of the production documentation for the product detailed above confirmed that the product 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 could be identified.It should be noted that the pulsar- 18 self-expanding stent system is indicated for use in patients with atherosclerotic disease of the femoral and proximal popliteal arteries.

Event Description

A pulsar-18 self-expandable stent system was selected for treatment of an acute artery dissection (60 percent stenosis degree) in a segment of the superior mesenteric artery.The complaint product was positioned inside the lesion.During the releasing process, the stent could only be released 2 - 3 mm.After that, the release mechanism was blocked.The product was withdrawn together with the stent without injury to the patient.Another stent was used to successfully finalize the intervention.

• 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: 18502337
• MDR Text Key: 332768386
• Report Number: 1028232-2024-00211
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 07640130430501
• UDI-Public: (01)07640130430501(17)2503
• 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
• Report Date: 01/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2024
• 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: 04220316
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2022
• 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