MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO 3.5/40; CORONARY DRUG-ELUTING STENT

Model Number	391020
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	04/01/2021
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 (95 percent stenosis degree) in the severely tortuous ostial lad.The orsiro could not pass the lesion and a stent deformation was detected.
Additional Manufacturer Narrative
Combination product: yes.The returned product was subjected to a technical analysis and the corresponding production documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for this event.In addition, the returned angiographic material was reviewed.The technical investigation of the returned instrument revealed that the stent is severely deformed at its distal end and slightly displaced in proximal direction.Microscopic analysis revealed stent imprints on the exposed balloon surface, indicating that the deformed struts were initially crimped on the balloon centered between the two x-ray markers.Outside of the deformed zone the diameter of the stent does not comply with the specification anymore.The content of the returned cd indicates that the films belong to a different intervention.The target vessel and the time stamps do not correspond to what was reported.Review of the production documentation confirmed that the instrument was manufactured according to specifications and passed all in-process and final inspections.As a part of final inspection every stent system undergoes visual inspection to ensure correct embedding and homogeneous crimping of the stent.Further, the stent outer diameter is verified to 100 percent and the stent retention force is tested for a defined amount of samples.Based on the conducted investigations, no manufacturing or material related root cause could be determined.

• Brand Name: ORSIRO 3.5/40
• 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: 11803314
• Report Number: 1028232-2021-02478
• Device Sequence Number: 3659539
• Product Code: NIQ
• UDI-Device Identifier: 07640130439450
• UDI-Public: 07640130439450
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• PMA/510(K) Number: P170030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2021

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: 02/27/2022
• Device Model Number: 391020
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 02202411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2021
• Initial Date Received by Manufacturer: 05/10/2021
• Supplement Date Received by Manufacturer: 07/13/2021
• Initial Report FDA Received Date: 05/10/2021
• Supplement Report FDA Received Date: 07/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1