MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PULSAR-18 6/120/135; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number 366839

Device Problem Malposition of Device (2616)

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

Event Date 12/11/2023

Event Type  malfunction  

Event Description

A pulsar-18 self-expandable stent system was selected for treatment of a moderately calcified lesion with 70 percent stenosis degree.During the procedure, when the physician released the stent, the stent moved forward and could not cover all of the lesion.He used another stent to finish the procedure.

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 verified that the product was manufactured according to specifications and fulfilled all the requirements of in-process and final inspection.Based on the conducted investigations of the device being subject to this complaint, no material or manufacturing related root cause was determined.

Manufacturer Narrative

11-jan-2024 additional information: the complaint product was positioned in the target lesion.The physician started to release the stent and difficulties during stent release were experienced.23-feb-2024 initially, lot 02235432 (pulsar-18 6/120/135) was reported for this report, (b)(4).Lot 07232923 (pulsar-18 5/150/135) was reported on (b)(4).After the technical investigation of the two returned products and additional correspondence with the local staff, it was confirmed that the lot numbers were accidentally mixed-up.This report, (b)(4) should be lot 07232923 (pulsar-18 5/150/135) 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 affected device was returned completely disassembled with one single part missing.The stent has been fully released.The outer shaft has been retracted by about 323 mm.The shaft is kinked at four different locations.Stent imprints are visible over a length of about 150 mm, indicating that the stent was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.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.

Manufacturer Narrative

11-jan-2024 additional information: the complaint product was positioned in the target lesion.The physician started to release the stent and difficulties during stent release were experienced.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 verified that the product was manufactured according to specifications and fulfilled all the requirements of in-process and final inspection.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 6/120/135
• 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: 18410241
• MDR Text Key: 331580224
• Report Number: 1028232-2023-06489
• 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,Followup
• Report Date: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 366839
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 02235432
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2023
• 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