MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PULSAR-18 T3 4/60/90; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	430440
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A pulsar-18 t3 self-expandable stent system was selected for treatment.During introduction of the device unbreachable resistance in the area of the sheath was felt.There were 2 insertion attempts, use of a 2nd stent catheter which also could not be advanced through the introducer.Subsequently.Image inspection of the sheath was made where the stent was seen mainly inside and about 1cm outside the sheath expanded intraluminal.The stent released in the introducer was advanced further into the vessel and remained there, to avoid a dilation in the puncture area during withdrawal.
Additional Manufacturer Narrative
(b)(6) 2023 new event details a pulsar-18 t3 stent system was chosen for treatment of a moderately calcified lesion (60 percent stenosis degree) in a mildly tortuous segment of the sfa.The complaint instrument was inserted into the introducer sheath, but strong resistance was felt inside of the introducer.The complaint instrument was withdrawn, and a second stent system was attempted to be inserted.This was impossible as the lumen of the introducer was occluded.An attempt was started to insert a support catheter over a 0.035 inch guidewire, but still could not pass the introducer.A control angiography was performed which shows the stent of the complaint instrument mostly inside of the introducer, but approximately 1 cm distally outside of the introducer in the afc.The support catheter was used off-label to successfully push the stent distally out of the introducer to prevent the expansion within the access site.The afc shows no flow restrictions.Due to the implantation of the stent in the afc, future access possibilities for this patient are limited.As the access was limited, the remaining stenosis and the dissection could not be treated within this intervention.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manufacturing process could be the cause for this event.The technical investigation revealed that the outer shaft has been retracted by about 6 mm.The stent has been fully pulled out of the instrument and was not returned for investigation.The outer shaft is compressed in its distal portion, indicating application of a pushing force despite meeting resistance.Outside of the deformed zone the outer shaft diameter complies with the specification.The device tip and the distal end of the retractable shaft show damages from the stent being pulled out of the instrument.Inspection of the remainder of the device revealed no other damage or irregularity.The introducer sheath used in the intervention was not returned, but this sheath is labeled with an inner diameter of 1.35 mm.However, the label and the ifu of the complaint instrument indicates a minimum inner diameter of 1.52 mm.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 could be determined.The root cause for the complaint event is most likely related to a tolerance issue with the introducer sheath used in the intervention.It should be noted that the ifu advises the user to exercise care during handling to reduce the possibility of deploying the stent prematurely, accidental breakage, bending or kinking of the delivery system shaft.

• Brand Name: PULSAR-18 T3 4/60/90
• Common Device Name: 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: 16103976
• Report Number: 1028232-2023-00064
• Device Sequence Number: 7654128
• Product Code: NIP
• UDI-Device Identifier: 07640130446380
• UDI-Public: (01)07640130446380(17)2509
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P160025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/26/2025
• Device Model Number: 430440
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 08223580
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2023
• Supplement Date Received by Manufacturer: 02/06/2023
• Initial Report FDA Received Date: 01/05/2023
• Supplement Report FDA Received Date: 02/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown