MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO (US) 3.0/40; CORONARY DRUG-ELUTING STENT

Model Number	404675
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/22/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The orsiro us drug-eluting stent system was selected for use.During treatment of a total occlusion by using a 7f extension catheter the stent got caught up in the edge of the extension catheter and was deformed.
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.The technical investigation of the returned instrument revealed that the stent is severely deformed; several stent struts are bent outwards at the distal end of the stent as well as in its middle.Judging from the x-ray markers the stent is not displaced.Microscopic analysis revealed stent imprints on the exposed balloon surface, indicating that the bent struts were initially crimped on the balloon.Outside of the deformed zone the crimped stent diameter does not comply with the specification anymore.Dried contrast medium was found inside of the balloon up to its distal end, indicating the application of vacuum.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.The device in question was manufactured according to specifications and successfully passed all in-process controls as well as the final inspection.Based on the conducted investigations, no manufacturing or material related root cause could be determined.The root cause for the complaint event is most likely related to the application of negative pressure to the delivery system prior to its positioning across the target lesion, which is clearly warned against in the ifu.

• Brand Name: ORSIRO (US) 3.0/40
• 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: 10393598
• Report Number: 1028232-2020-03357
• Device Sequence Number: 1875137
• Product Code: NIQ
• UDI-Device Identifier: 07640130439443
• UDI-Public: 07640130439443
• Combination Product (Y/N): N
• 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): 07/23/2020

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: 04/14/2021
• Device Model Number: 404675
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 03197326
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2020
• Initial Date Received by Manufacturer: 07/23/2020
• Supplement Date Received by Manufacturer: 09/29/2020
• Initial Report FDA Received Date: 08/11/2020
• Supplement Report FDA Received Date: 09/29/2020
• 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