MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PULSAR-18 T3 6/200/90; STENT

Model Number 430466

Device Problem Failure to Advance (2524)

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

Event Date 11/15/2021

Event Type  malfunction  

Event Description

A pulsar 18 t3 peripheral stent system was selected for treatment of a predilated lesion.It was not possible to place the pulsar 18 t3 stent at its intended position inside the target lesion as it got stuck inside the 4f introducer sheath.

Manufacturer Narrative

The returned product 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cause for the reported event.The technical investigation of the returned instrument revealed that the outer shaft has been retracted by about 6 mm.The distal end of the stent has been released.The outer shaft is kinked and compressed in its distal portion.Outside of the deformed zone the diameter of the outer shaft still complies with the specification.The introducer sheath used in the intervention was not returned for analysis.Due to the state of the instrument, it could not be inserted through a reference introducer sheath.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.During final inspection, the outer shaft of every stent system undergoes visual inspection and a 100 percent control of the outer shaft diameter is performed.Based on the conducted investigations of the device being subject to this complaint, no material or manufacturing related root cause was determined.The root cause for the complaint event is most likely related to a tolerance issue with the introducer sheath used in the intervention.

• Brand Name: PULSAR-18 T3 6/200/90
• Type of Device: STENT
• 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: 13112551
• MDR Text Key: 282964120
• Report Number: 1028232-2021-06947
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 07640130446649
• UDI-Public: 07640130446649
• 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: Foreign,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 430466
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 05215923
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/27/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/11/2021
• 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