MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO 3.5/22; CORONARY DRUG-ELUTING STENT

Model Number 364503

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Death (1802); Thrombosis (2100)

Event Date 05/27/2020

Event Type  Death  

Event Description

An orsiro drug-eluting stent system was selected for treatment.20 day after primary intervention patient experienced chest pain.Stent thrombosis was detected.Pcta was done, blood flow was resolved but patient remained in icu.The day after patient passed away.The physician stated that the thrombosis occurred due to discontinuing antiplatelet medicine.

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.There are a number of factors contributing to stent thrombosis.In the present case appropriate preventative measures were taken, but antiplatelet/anticoagulation medication was discontinued independently two days after stent implantation.The root cause for the complaint event is therefore most likely related to external factors, i.E.The discontinuation of prescribed antiplatelet/anticoagulation medication.

• Brand Name: ORSIRO 3.5/22
• 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: 10123422
• MDR Text Key: 194141222
• Report Number: 1028232-2020-02281
• Device Sequence Number: 1
• Product Code: NIQ
• 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: 06/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2021
• Device Model Number: 364503
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 07193094
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death