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

Model Number 404669

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Cardiac Arrest (1762); Thrombosis/Thrombus (4440)

Event Date 10/25/2021

Event Type  Injury  

Manufacturer Narrative

Combination product: yes.

Event 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.

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
• Type of Device: 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
• MDR Text Key: 280585579
• Report Number: 1028232-2021-06075
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 07640130439382
• UDI-Public: 07640130439382
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P170030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 02/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Life Threatening
• Patient Sex: Male