MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO 2.75/40; CORONARY DRUG-ELUTING STENT

Model Number 391240

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Thrombosis (2100)

Event Date 11/25/2019

Event Type  Injury  

Event Description

An orsiro drug-eluting stent system was selected to treat a lesion (75 percent stenosis degree) in the lad.3 days after implantation patient experienced chest pain and a stent thrombosis was detected.Aspiration was done.

Manufacturer Narrative

Neither the complaint instrument nor the angiographic material was available for analysis.Therefore no technical investigation on the subject could be performed.The production documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.Review of the production documentation confirmed that the instrument was manufactured according to specifications and passed all in-process and final inspections.Based on the conducted investigations no manufacturing related root cause was determined.However, it was reported that the antiplatelet drug may have been weakened due to genetic factors or interaction with other drugs (vonoprazan) and that the thrombosis is not related to the complaint stent.

• Brand Name: ORSIRO 2.75/40
• 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: 9558037
• MDR Text Key: 173928934
• Report Number: 1028232-2020-00083
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 07640130439436
• UDI-Public: 07640130439436
• Combination Product (y/n): N
• 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: 01/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/25/2020
• Device Model Number: 391240
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 07181534
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1