MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO 2.5/13; CORONARY DRUG-ELUTING STENT

Model Number 419108

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 06/14/2021

Event Type  Injury  

Manufacturer Narrative

Combination product: yes.

Event Description

An orsiro mission drug-eluting stent system was selected for treatment.3 days after index procedure patient experienced retrosternal pain and a thrombosis was detected.It was stated that the patient did not take the prescribed clopidogrel.Stent details and lot number unknown.

Manufacturer Narrative

Combination product: yes.Size and lot number of device updated.Three days after the successful index procedure coronary angiography revealed a subocclusive stent thrombosis plaque at the previously implanted orsiro stent.The provided clinical information and cec adjudication suggested the total discontinuation of dual antiplatelet therapy as a predisposing factor for the observed st.However, 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.

Manufacturer Narrative

Combination product: yes size and lot number of device updated.

• Brand Name: ORSIRO 2.5/13
• 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: 12099178
• MDR Text Key: 259360188
• Report Number: 1028232-2021-03692
• 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,Followup
• Report Date: 06/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/04/2022
• Device Model Number: 419108
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 09200476
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention