MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO MISSION 2.5/18; CORONARY DRUG-ELUTING STENT

Model Number 419120

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 09/25/2021

Event Type  Injury  

Manufacturer Narrative

Combination product: yes.

Event Description

An orsiro mission drug-eluting stent system was selected for treatment in context of the dapt-study.A late stent thrombosis was reported in the distal rca.Patient experienced stemi and was admitted to the hospital.Angiography showed a stent thrombosis in the target lesion.Revascularization of target lesion, implantation of an additional orsiro mission stent and medication therapy was performed with good outcome.

Manufacturer Narrative

Combination product: yes.After the successful index procedure of two distal rca lesions, the patient developed a late stent thrombosis (107d) with confirmed inferior stemi.The affected device was not returned and could therefore not be subjected to a technical investigation.The review of the index angiographic images revealed severe stenosis of two distal rca segments treated successfully by des placement.Further, the review of the ae angiographic images confirmed the reported flow-limiting st in the distal rca, which was treated with des placement.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 adjudicated the case as spontaneous mi with late st due to clinical reasons.

• Brand Name: ORSIRO MISSION 2.5/18
• 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 Key: 12631212
• MDR Text Key: 276349280
• Report Number: 1028232-2021-05691
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: CH
• PMA/PMN Number: P170030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/11/2022
• Device Model Number: 419120
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 10203125
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2020
• 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