MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PULSAR-18 5/170/135; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number 366836

Device Problem Difficult to Remove (1528)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/11/2020

Event Type  Injury  

Event Description

A pulsar-18 peripheral stent system was selected for treatment of a severely calcified lesion (95 percent stenosis degree) in a mildly tortuous mid left superficial femoral artery.After stent release during attempt to remove the system, the guide wire and stent system were twined together and could not be withdrawn.Eventually it was necessary to perform an incision to take out the guidewire, stent and stent system.

Manufacturer Narrative

The returned device 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 this event.Further, the angiographic material was reviewed.The technical investigation of the returned delivery system revealed that the outer shaft has been retracted by about 765 mm.The outer shaft was inspected for stent imprints.The length of the imprints was measured and implies that the stent had the correct length prior to release.The provided angiographic material show the implanted complaint stent.Geometric distortions of the stent structure are visible as well as the attempt to withdraw the complaint instrument.The inhomogeneous radiopacity along the stent length is indicative of stent compression.The actual complaint event is not visible.Review of the production documentation confirmed that the instrument was manufactured according to specifications and passed all in-process and final inspections.A 100 percent stent length control is conducted during the manufacturing process.Based on the conducted investigations no manufacturing related root cause could be determined.It seems likely that the reported event is related to the handling of the device.Any slack in the delivery system outside the patient could result in incorrect stent placement, potential stent compression or elongation as stated in the instruction for use.

• Brand Name: PULSAR-18 5/170/135
• 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: 10511718
• MDR Text Key: 206290347
• Report Number: 1028232-2020-03838
• 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: 09/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: 366836
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 12184271
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2020
• Date Manufacturer Received: 03/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1