MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PULSAR-18 T3 6/200/135; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	430506
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2021
Type of Reportable Event	Malfunction
Event or Problem Description
A pulsar-18 t3 6/200/135 peripheral stent system was selected for treatment.The stent was deployed in the politeal p1 and sfa.However, the stent seems to be much shorter than the actual length which is described on the packaging.Thus, a passeo-18 (6/200) was used to measure the stent length and the stent was found to be about 40mm shorter that the passeo-18.
Additional Manufacturer Narrative
Neither the complaint instrument nor the angiographic material was returned for analysis.Therefore, no technical investigation on the subject could be performed.The production documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.One photograph taken from the angiogram was provided.It shows an inflated balloon with a length of 200 mm inside the complaint stent.The fully released stent appears to be 40 mm shorter than the balloon.Unfortunately, the poor quality of the photograph does not allow any statement with regards to geometric distortions of the stent structure and/or inhomogeneous radiopacity along the stent length which would be suggestive of focal stent compression.Despite extensive correspondence with the local staff the original angiographic material could not be obtained.Review of the production documentation confirmed that the instrument was manufactured according to specifications and passed all in-process and final inspections.Based on the conducted investigations, no material or manufacturing related root cause could be determined.

• Brand Name: PULSAR-18 T3 6/200/135
• 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: 12185334
• Report Number: 1028232-2021-04028
• Device Sequence Number: 16549841
• Product Code: NIP
• UDI-Device Identifier: 07640130447042
• UDI-Public: 07640130447042
• 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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2021

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: 10/14/2023
• Device Model Number: 430506
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 10200784
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2021
• Supplement Date Received by Manufacturer: 11/05/2021
• Initial Report FDA Received Date: 07/16/2021
• Supplement Report FDA Received Date: 11/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2020
• 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