MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO (US) 3.0/35; CORONARY DRUG-ELUTING STENT

Model Number	404669
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Thrombosis/Thrombus (4440)
Date of Event	10/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Combination product: yes.
Event or Problem Description
7 days after the orsiro drug-eluting stent implantation in the prox.Lad, the patient returned to the hospital with a cardiac arrest.A 100 percent subacute stent thrombosis was detected and treated with aspiration thrombectomy and a balloon dilation inside the stent.
Additional Manufacturer Narrative
Combination product: yes.After the successful index procedure, the patient developed a subacute stent thrombosis after 7 days.The affected device was not returned and could therefore not be subjected to a technical investigation.The review of provided angiographic still images revealed no additional information.The review of the product release documentation confirmed that the device was manufactured according to specifications and fulfilled all the in-process and final inspection requirements.Based on the provided documentation, no device deficiency or manufacturing related root cause could be identified.

• Brand Name: ORSIRO (US) 3.0/35
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BIOTRONIK AG, BUELACH, SWITZERLAND; ackerstrasse 6; buelach CH-81 80; CH CH-8180
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 12787400
• Report Number: 1028232-2021-06075
• Device Sequence Number: 14404860
• Product Code: NIQ
• UDI-Device Identifier: 07640130439382
• UDI-Public: 07640130439382
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: P170030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2021

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: 07/08/2023
• Device Model Number: 404669
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 06216099
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2021
• Supplement Date Received by Manufacturer: 02/16/2022
• Initial Report FDA Received Date: 11/10/2021
• Supplement Report FDA Received Date: 02/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Life Threatening
• Patient Sex: Male