MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO 3.0/15; CORONARY DRUG-ELUTING STENT

Model Number 364484

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Thrombosis (2100)

Event Date 07/18/2019

Event Type  Injury  

Event Description

An orsiro drug-eluting stent system was chosen to treat a lesion (100 percent stenosis degree) in a rca.15 to 30 minutes after implantation st elevation was observed.A stent thrombosis has occurred.

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 manufacturing history 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 possibly the antiplatelet agent was not effective which may have contributed to this incident.

• Brand Name: ORSIRO 3.0/15
• 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: 8885932
• MDR Text Key: 154093729
• Report Number: 1028232-2019-03375
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 07640130438996
• UDI-Public: 07640130438996
• 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: 08/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/05/2020
• Device Model Number: 364484
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 01182891
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1