MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO MISSION (US) 3.5/22; CORONARY DRUG-ELUTING STENT

Model Number	453953
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	06/08/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Combination product: yes.
Event or Problem Description
An orsiro mission drug-eluting stent system was selected for treatment of a mildly calcified lesion (95 percent stenosis degree) in the mildly tortuous mid rca.An acute stent thrombosis occurred 1.5 h after implantation of the orsiro mission stent.After ballooning of the stent thrombosis, a timi 3 flow was re-established.Patient was loaded on aspirin and plavix after initial procedure.Iv cangrelor was given during repeat intervention to open thrombosed stent.Patient was transferred to heart cath recovery for duration of cangrelor drip and then transferred to icu.One day after procedure the patient was doing great and was discharged home.
Additional Manufacturer Narrative
Combination product: yes.The affected product was not returned to biotronik and could therefore not be subjected to a technical investigation.Images of the case such as angiographies or other relevant clinical information could not be obtained.Review of the product release documentation confirmed that the device in question was manufactured according to specifications and fulfilled all the requirements of in-process and final inspection.Based on the reviewed documentation no device deficiency or manufacturing-related root cause could be identified.Since medication was changed between the first and the second intervention, dapt effectiveness may have been a contributing factor to the reported event which could not be confirmed.Please note that, according to the orsiro mission us ifu, administration of appropriate anticoagulant, antiplatelet and vasodilation therapy is critical to successful stent implantation.

• Brand Name: ORSIRO MISSION (US) 3.5/22
• 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: 17206215
• Report Number: 1028232-2023-03198
• Device Sequence Number: 20532641
• Product Code: NIQ
• UDI-Device Identifier: 07640130456099
• UDI-Public: (01)07640130456099(17)2401
• 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: 2023
• 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): 08/02/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/24/2024
• Device Model Number: 453953
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 01221284
• 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: 06/09/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/26/2023
• Supplement Report FDA Received Date: 08/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2022
• 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: Required Intervention; Hospitalization
• Patient Age: 68 YR
• Patient Sex: Female