MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO MISSION 4.0/18; CORONARY DRUG-ELUTING STENT

Model Number 419124

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 09/30/2020

Event Type  Injury  

Manufacturer Narrative

Combination product: yes.

Event Description

On (b)(6) 2020, the orsiro mission stent was successfully implanted into a bypass graft.On (b)(6) 2020 patient experienced chest pain but was discharged the same day because troponin i showed normal values.On (b)(6) 2020 patient presented again with chest pain and was put on ppi (proton pump inhibitor) treatment for 14 days and was discharged the next day.On (b)(6) 2020 patient was hospitalized again with non-st-elevation acute myocardial infarction.On (b)(6) 2020 a thrombosis in the bypass graft was detected.It was stated that the occlusion of vein graft occurred probably due to occlusion of the orsiro stent, probably due to distal edge dissection after post-dilatation which was not detected at the index pci.

Manufacturer Narrative

Combination product: yes 165 days after the successful index procedure coronary angiography revealed late stent thrombosis in a vein graft, at the level of the des previously placed.The provided clinical information was insufficient to establish whether a device deficiency contributed to this event but the hospital identified a probable relationship to the index procedure (distal edge dissection after post-dilation not detected at the index pci).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 and the conducted review, no device deficiency or manufacturing-related root cause could be identified.According to the treating physician, further revascularization is not possible; medical treatment, including dapt is to be continued.

• Brand Name: ORSIRO MISSION 4.0/18
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BIOTRONIK AG, BUELACH, SWITZERLAND; ackerstrasse 6; buelach CH-81 80; CH CH-8180
• MDR Report Key: 11925607
• MDR Text Key: 253979931
• Report Number: 1028232-2021-03053
• 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: 06/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/04/2021
• Device Model Number: 419124
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 08193359
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1