MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ASTRON 9/40/120; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number 343794

Device Problems Device Dislodged or Dislocated (2923); Material Deformation (2976)

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

Event Date 11/25/2020

Event Type  malfunction  

Event Description

An astron self-expanding stent system was chosen for treatment of a mildly calcified lesion (80 percent stenosis degree) in the inferior genicular artery.After predilatation of the lesion the device could not pass the introducer sheath and dislodged inside the sheath.After withdrawal it was detected that the stent was also deformed on the distal end.Another device was used to complete the intervention.

Manufacturer Narrative

The returned product was subjected to a technical analysis and the corresponding production documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for this event.The technical investigation revealed that the safety tab has been removed and the sliding t-connector has been pulled in proximal direction.The outer shaft has been retracted by about 9 cm.The diameter of the outer shaft complies with the specification.The stent was returned separately and shows no damage or irregularity.Review of the production documentation verified that the instrument was manufactured according to specifications.The device 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 could be determined.The root cause for the complaint event is most likely related to the handing during device introduction.It should be noted that the ifu clearly advises the user to remove the safety tab and immobilize the stainless steel tube after device introduction.The user is further advised to never pull back the sliding t-connector during insertion of the delivery system.

• Brand Name: ASTRON 9/40/120
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): BIOTRONIK AG, BUELACH, SWITZERLAND; ackerstrasse 6; buelach CH-81 80; CH CH-8180
• MDR Report Key: 10984818
• MDR Text Key: 220708678
• Report Number: 1028232-2020-05415
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• PMA/PMN Number: P160025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: 343794
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 08194406
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2021
• Initial Date Manufacturer Received: 12/09/2020
• Initial Date FDA Received: 12/10/2020
• Supplement Dates Manufacturer Received: 03/11/2021
• Supplement Dates FDA Received: 03/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1