MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO MISSION 2.75/15; CORONARY DRUG-ELUTING STENT

Model Number 419115

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 01/21/2021

Event Type  Injury  

Manufacturer Narrative

Combination product: yes.

Event Description

An orsiro drug eluting stent system was selected for treatment in context of a (b)(6) study.The stent was implanted.The procedure is marked by the occurrence of an acute stent thrombosis with timi2 flow after post dilation, treated by 6f thromboaspiration to restore timi3 flow.

Manufacturer Narrative

Combination product: yes.After des placement in a tight cx stenosis an intraprocedural stent thrombosis was observed after post-dilatation, successfully treated with dilatation and thromboaspiration.No complication after the procedure were reported.The affected device was not returned and could therefore not be subjected to a technical investigation.However, the review of the provided angiographic images supported the reported sequence.The 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.The clinical event committee event adjudicated the case as periprocedural mi with intraprocedural st due to clinical reasons.

• Brand Name: ORSIRO MISSION 2.75/15
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BIOTRONIK AG, BUELACH, SWITZERLAND; ackerstrasse 6; buelach CH-81 80; CH CH-8180
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 12196878
• MDR Text Key: 262458909
• Report Number: 1028232-2021-04067
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: CH
• PMA/PMN Number: P170030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/04/2021
• Device Model Number: 419115
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 11191475
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention