MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PULSAR-18 T3 5/150/135; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	430494
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2022
Type of Reportable Event	Malfunction
Additional 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process could be the cause for the reported event.The technical investigation revealed that the outer shaft has been retracted by about 8 mm, which explains the physicians impression of the loose tip.The stent has not been released and is still fully crimped under the retractable outer shaft.The outer shaft is compressed in its distal portion, indicating application of a pushing force despite meeting resistance.The distal end of the outer shaft and the device tip show severe indentations and scratches.In addition, in the stent area the outer layer of the outer shaft is scraped off.Outside of the deformed zone the outer shaft diameter complies with the specification.Inspection of the remainder of the device revealed no other damage or irregularity.The 6f introducer sheath used in the intervention was not returned for analysis.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 the patients anatomy.The severe indentations and scratches were caused by application of a mechanical load from the outside, e.G.When attempting to cross the previously implanted stent.It should be noted that the ifu states to stent the distal lesion segment first and to take caution when crossing a previously implanted stent.
Event or Problem Description
Pulsar-18 t3 stent systems were chosen for treatment of the sfa.After predilatation and a successfully antegrade placement of a pulsar-18 t3 stent size 5/200/135, an extension was needed.The complaint pulsar-18 t3 was advanced through the first placed stent, when resistance was felt.The stent was withdrawn out of the patient, and it was detected that the distal end of the catheter could be moved back and forth, separately from the shaft of the sds.Originally reported on mdr-1028232-2022-06476, but was on wrong lot number.That report has been closed and reporting correct information on this report.

• Brand Name: PULSAR-18 T3 5/150/135
• 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: 16281364
• Report Number: 1028232-2023-00527
• Device Sequence Number: 12458953
• Product Code: NIP
• UDI-Device Identifier: 07640130446922
• UDI-Public: (01)07640130446922(17)2310
• 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
• Report Date (Section B): 01/31/2023

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: 01/13/2024
• Device Model Number: 430494
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 10200768
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2023
• Initial Report FDA Received Date: 02/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/12/2020
• 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