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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO MISSION 3.0/18; CORONARY DRUG-ELUTING STENT
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BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO MISSION 3.0/18; CORONARY DRUG-ELUTING STENT Back to Search Results
Model Number 419122
Device Problem Patient Device Interaction Problem (4001)
Patient Problem Thrombosis/Thrombus (4440)
Event Date 10/19/2021
Event Type  Injury  
Manufacturer Narrative
Combination product: yes.
 
Event Description
In context of the (b)(6) study on (b)(6) 2021 an orsiro mission drug eluting stent system was selected for treatment of severely calcified lesion with 80 percent stenosis degree and a length of 15mm in the moderately tortuous proximal rca.4 months after stent implantation the patient complained about dyspnea.A coronary angiography was performed on (b)(6) 2021, showing intrastent occlusion on rca.An attempt to re-open the vessel will be planned ad hoc.
 
Manufacturer Narrative
Combination product: yes.Four months after the successful index procedure an elective coronary angiography showed a proximal right coronary artery occlusion less than three months old.According to the hospital, the clinical context would rather suggest a proliferative restenosis leading to progressive occlusion, but late subacute thrombosis could not be excluded 100 percent.The affected device was not returned and could therefore not be subjected to a technical investigation.The review of the baseline angiographic images confirmed severe prox.Rca stenosis treated successfully by des placement.Further, the review of the adverse event angiographic images confirmed unsuccessful rca revascularization.The discharge letter stated that a new attempt at right coronary recanalization should be propose to the patient.However, a 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.The clinical event committee event assessed the case as silent occlusion.
 
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Brand Name
ORSIRO MISSION 3.0/18
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 Key12745705
MDR Text Key279875004
Report Number1028232-2021-06014
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeCH
PMA/PMN Number
P170030
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/03/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date12/01/2022
Device Model Number419122
Device Catalogue NumberSEE MODEL NO.
Device Lot Number10206604
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/11/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/01/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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