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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO MISSION 2.5/22 CORONARY DRUG-ELUTING STENT

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BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO MISSION 2.5/22 CORONARY DRUG-ELUTING STENT Back to Search Results
Model Number 419126
Device Problem Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/09/2021
Event Type  malfunction  
Event Description
An orsiro mission drug-eluting stent system was selected for treatment. When opening the sterile pouch, it was detected that a stent strut was damaged. The device was not used.
 
Manufacturer Narrative
The complaint instrument was not returned. Therefore, no technical investigation on the subject could be performed. The product release documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event. Review of the product release documentation confirmed that the instrument was manufactured according to specifications and passed all in process and final inspections. As a part of final inspection every stent system undergoes visual inspection to ensure correct embedding and homogeneous crimping of the stent. Based on the conducted investigations of the device being subject to this complaint, no material or manufacturing related root cause was determined.
 
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Brand NameORSIRO MISSION 2.5/22
Type of DeviceCORONARY 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 Key13122157
MDR Text Key283175426
Report Number1028232-2021-06988
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
P170030
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/29/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number419126
Device Catalogue NumberSEE MODEL NO.
Device Lot Number05215018
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/29/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/06/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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