MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PULSAR-18 T3 7/40/135; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	430509
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The pulsar-18 t3 self-expandable stent was deployed in the sfa.The stent looked longer than advertised length.Measurement on angiographic picture showed > 40mm.Deployment proceeded as usual with no movement or elongation of the stent.
Additional Manufacturer Narrative
On 19-jun-2024, additional information was received that the treated was a moderately calcified lesion (80 percent stenosis degree, vessel reference diameter 6 mm, lesion length 30 mm) in a mildly tortuous part of the distal sfa.The lesion was pre-dilated.Neither the affected device nor the angiographic material was returned.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.In addition, one photograph taken from the angiogram was reviewed.The photograph provided shows the stent after its release in the sfa.Inside the released stent, two radiopaque markers are visible.The length of the stent is marked 55.09 mm.Geometric distortions of the stent structure are recognizable.The inhomogeneous radiopacity in the proximal stent portion may be suggestive of a focal stent elongation.Unfortunately, the quality of the photograph is rather poor and there are visual limitations from anatomical structures (i.E.Femoral bone, calcium in the artery).Review of the production documentation confirmed that the device was manufactured according to specifications and fulfilled all the requirements of in-process and final inspection.Based on the conducted investigations, no material or manufacturing related root cause could be determined.
Additional Manufacturer Narrative
Corrected the initial reporter information.Reference capa# nc-24-004.Neither the affected device nor the angiographic material was returned.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.In addition, one photograph taken from the angiogram was reviewed.The photograph provided shows the stent after its release in the sfa.Inside the released stent, two radiopaque markers are visible.The length of the stent is marked 55.09 mm.Geometric distortions of the stent structure are recognizable.The inhomogeneous radiopacity in the proximal stent portion may be suggestive of a focal stent elongation.Unfortunately, the quality of the photograph is rather poor and there are visual limitations from anatomical structures (i.E.Femoral bone, calcium in the artery).Review of the production documentation confirmed that the device was manufactured according to specifications and fulfilled all the requirements of in-process and final inspection.Based on the conducted investigations, no material or manufacturing related root cause could be determined.

• Brand Name: PULSAR-18 T3 7/40/135
• 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: 19415269
• Report Number: 1028232-2024-02904
• Device Sequence Number: 3264238
• Product Code: NIP
• UDI-Device Identifier: 07640130447073
• UDI-Public: (01)07640130447073(17)2610
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/12/2024

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 Model Number: 430509
• Device Catalogue Number: 430509
• Device Lot Number: 09234473
• 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: 05/28/2024
• Supplement Date Received by Manufacturer: 06/19/2024; 11/12/2024
• Initial Report FDA Received Date: 05/29/2024
• Supplement Report FDA Received Date: 06/19/2024; 11/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2023
• 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