MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO (US) 3.0/15; CORONARY DRUG-ELUTING STENT

Model Number	401744
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2021
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 in a moderately tortuous mid rca.Multiple attempts were made to cross a previously implanted stent.After pulling the device out it was detected that struts on the stent were damaged.A 6 f guideliner was used during procedure.This was the first of two orsiro stents that failed in this case.The second device is reported separately.
Additional Manufacturer Narrative
Combination product: yes.The device lot number and size was not included on original reported.It has been added to this report.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.The technical investigation of the returned instrument revealed that the stent not deformed or damaged.The balloon is well folded and shows no signs of inflation.The crimped diameter of the stent still complies with the specification.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 the 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.Based on the conducted investigations, no manufacturing or material related root cause could be determined.

• Brand Name: ORSIRO (US) 3.0/15
• 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: 11255147
• Report Number: 1028232-2021-00546
• Device Sequence Number: 3977013
• Product Code: NIQ
• UDI-Device Identifier: 07640130438996
• UDI-Public: 07640130438996
• 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): 01/15/2021

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 Model Number: 401744
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 04200674
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2021
• Initial Date Received by Manufacturer: 01/15/2021
• Supplement Date Received by Manufacturer: 04/08/2021
• Initial Report FDA Received Date: 01/29/2021
• Supplement Report FDA Received Date: 04/09/2021
• 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