MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO MISSION; CORONARY DRUG ELUDING STENT

Catalog Number SEE MODEL NO.

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 06/29/2021

Event Type  Injury  

Manufacturer Narrative

Combination product: yes.

Event Description

In context of the dapt study an orsiro mission drug eluting stent system was selected for treatment.The patient experienced retrosternal pain with radiation to the left arm on the night of (b)(6) 2021.After 45 minutes, patient was symptom free again.Patient had a scheduled cardiological control on (b)(6).During the check-up the ecg showed st elevations and a troponin elevation.Immediate transfer to the hospital for coronary angiography with suspected stent thrombosis.On (b)(6) 2021 a coronary angiography due to suspected stent thrombosis was done but no changes to previous angiography.Site assumes a passive stent thrombosis which has been completely recanalized in the meantime.Lot number unknown.

Manufacturer Narrative

Combination product: yes three months after the successful elective coronary treatment the patient developed myocardial infarction (mi) due to transient late stent thrombosis which was not evident anymore by coronary angiography at the time of readmission at the hospital.The clinical event committee rated the occurrence as spontaneous mi without vessel obstruction and probably resolved stent thrombosis.The review of the product release documentation confirmed that the device was manufactured according to specifications and fulfilled all the requirements of in-process and final inspection.Based on the provided documentation no device deficiency or manufacturing related root cause could be identified.

• Brand Name: ORSIRO MISSION
• Type of Device: CORONARY DRUG ELUDING STENT
• Manufacturer (Section D): BIOTRONIK AG, BUELACH, SWITZERLAND; ackerstrasse 6; buelach CH-81 80; CH CH-8180
• MDR Report Key: 12236285
• MDR Text Key: 263810409
• Report Number: 1028232-2021-04214
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• PMA/PMN Number: P170030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention