MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PULSAR-18 US 4/150/135; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	390709
Medical Device Problem Codes	Fracture (1260); Difficult to Remove (1528); Activation Failure (3270)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/29/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
A pulsar-18 peripheral stent system was selected for treatment of a moderately calcified lesion (50 percent stenosis degree) in a moderately tortuous unknown vessel.The release mechanism jammed and broke.The stent was partially deployed.It was not possible to fully deploy or retrieve the stent.Fragment of the stent was left in puncture site.
Additional Manufacturer Narrative
The returned product was subjected to a 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.Only the distal portion of the delivery system and two stent fragments were returned for analysis.The 214 mm long device fragment shows a strong kink about 105 mm proximal to its distal end.The outer shaft is retracted by about 44 mm.Outside of the deformed zone the outer shaft diameter still complies with the specification.One stent fragment was located under the retractable outer shaft whereas the other stent fragment was located inside the distal portion of an introducer sheath fragment.Both stent fragments are severely deformed, indicating application of a high tensile force.Due to the state of the instrument, an investigation with regards to the reported complaint event is not possible.Review of the product release documentation confirmed that the instrument was manufactured according to specifications and passed all in-process and final inspections.Based on the conducted investigations, no manufacturing or material related root cause could be determined.The final root cause could not be established.It should be noted that, according to the ifu, the pulsar-18 stent system is indicated for use in the superficial femoral or proximal popliteal arteries.

• Brand Name: PULSAR-18 US 4/150/135
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): BIOTRONIK AG, BUELACH, SWITZERLAND; ackerstrasse 6; buelach CH-81 80; CH CH-8180
• MDR Report Key: 12438710
• Report Number: 1028232-2021-04993
• Device Sequence Number: 17528020
• Product Code: NIP
• UDI-Device Identifier: 07640130436466
• UDI-Public: 07640130436466
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P160025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: 390709
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 10194774
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/25/2021
• Supplement Date Received by Manufacturer: 10/20/2021
• Initial Report FDA Received Date: 09/08/2021
• Supplement Report FDA Received Date: 10/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention