MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO (US) 2.5/15; CORONARY DRUG-ELUTING STENT

Model Number	401742
Medical Device Problem Codes	Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Combination product: yes.
Event or Problem Description
An orsiro drug-eluting stent system was selected for treatment of a severely calcified lesion (90 percent stenosis degree) in the severely tortuous mid cx.Stent would not cross lesion and after removal it was noticed that the stent was damaged.Multiple stents were attempt to be inserted but nothing was able to cross.
Additional Manufacturer Narrative
Combination product: yes.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.Review of the production documentation for the product detailed above verified that the instrument was manufactured according to specifications and fulfilled all the requirements of in-process and final inspection.During final inspection, every stent system undergoes visual inspection to ensure correct stent embedding and homogeneous crimping of the stent.Further, the stent outer diameter is verified to 100 percent.Based on the conducted investigations of the device being subject to this complaint, no material or manufacturing related root cause was determined.Considering the physicians event description, it seems likely that the root cause for the complaint event is related to the patients anatomy (severely tortuous and calcified lesion).

• Brand Name: ORSIRO (US) 2.5/15
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BIOTRONIK AG, BUELACH, SWITZERLAND; ackerstrasse 6; buelach CH-81 80; CH CH-8180
• MDR Report Key: 11806271
• Report Number: 1028232-2021-02506
• Device Sequence Number: 19810759
• Product Code: NIQ
• UDI-Device Identifier: 07640130438972
• UDI-Public: 07640130438972
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: P170030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 04/26/2021

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: 11/17/2021
• Device Model Number: 401742
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 10196523
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/26/2021
• Supplement Date Received by Manufacturer: 06/15/2021
• Initial Report FDA Received Date: 05/11/2021
• Supplement Report FDA Received Date: 06/16/2021
• 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: Hospitalization
• Patient Age: 55 YR