MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PULSAR-18 5/150/135; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number 366835

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 11/17/2022

Event Type  malfunction  

Event Description

A pulsar-18 self-expandable stent system was selected for treatment of a severely calcified lesion (90 percent stenosis degree) in the moderately tortuous proximal right sfa.A passeo-18 balloon was used for dilatation, but the angiography showed no good result.Then the pulsar-18 was advanced but could not pass the lesion.A cutting balloon was used for additional dilatation, and another stent was successfully implanted.

Manufacturer Narrative

Neither the complaint instrument nor the angiographic material was returned.Therefore, no technical investigation on the subject could be performed.The product release documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.Review of the product release documentation confirmed that the device 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 5/150/135
• 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: 15931528
• MDR Text Key: 304965947
• Report Number: 1028232-2022-06189
• 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
• Report Date: 12/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 366835
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 09215404
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2021
• 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