MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO 2.5/35; CORONARY DRUG-ELUTING STENT

Model Number	391235
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	05/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Combination product: yes.
Event or Problem Description
An orsiro drug-eluting stent system was selected for treatment.Two days after implantation of the orsiro a stent thrombosis was detected.Treatment with drug coated balloon and iabp.
Additional Manufacturer Narrative
Combination product: yes.Two days after the successful index procedure coronary angiography revealed plaque at the previously implanted orsiro stent.Aspiration was done and two additional des were implanted to cover the plaque section.For the lesion where the orsiro stent was implanted, dcb treatment was done.The hospital commented that it is unknown whether the orsiro stent caused the st or not.As a hypothesis for the reported event, a vessel injury during ivus was stated.The provided clinical information was insufficient to establish whether a device deficiency contributed to this event.However, review of the product release documentation confirmed that the device was manufactured according to specifications and fulfilled all the requirements of in-process and final inspection.Based on the provided documentation no device deficiency or manufacturing related root cause could be identified.

• Brand Name: ORSIRO 2.5/35
• 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: 11957219
• Report Number: 1028232-2021-03206
• Device Sequence Number: 14553703
• Product Code: NIQ
• UDI-Device Identifier: 07640130439368
• UDI-Public: 07640130439368
• 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,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/20/2022
• Device Model Number: 391235
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 02206646
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/07/2021
• Supplement Date Received by Manufacturer: 09/08/2021
• Initial Report FDA Received Date: 06/08/2021
• Supplement Report FDA Received Date: 09/09/2021
• 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: Required Intervention