MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO MISSION 2.5/35; CORONARY DRUG-ELUTING STENT

Model Number 419144

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Myocardial Infarction (1969); Thrombosis/Thrombus (4440)

Event Date 02/22/2023

Event Type  Injury  

Manufacturer Narrative

Combination product: yes.

Event Description

15 days after initial treatment with placement of two orsiro mission drug eluting stents in a mildly calcified lesion (95 percent stenosis degree) in the mid rca.The patient was transferred to the hospital with an acute inferior myocardial infarction.During the emergency cag, a complete thrombus occlusion was noticed on the distal part of the rca.After repeated aspiration and balloon dilatations, timi 3 flow was obtained.An aortic balloon pumping (iabp) was inserted to secure coronary artery blood flow.Two days later the iabp was removed.Patient was discharged home.The second stent is reported separately.

Manufacturer Narrative

Combination product: yes.The affected orsiro mission stent systems were not returned to biotronik and could therefore not be subjected to a technical investigation.Images of the case such as angiographies or other relevant clinical information could not be obtained.Review of the product release documentation confirmed that the devices were manufactured according to specifications and fulfilled all the requirements of in-process and final inspection.Based on the reviewed documentation no device deficiency or manufacturing-related root cause could be identified.

• Brand Name: ORSIRO MISSION 2.5/35
• 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: 16645705
• MDR Text Key: 312344687
• Report Number: 1028232-2023-01600
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 07640130442047
• UDI-Public: (01)07640130442047(17)2405
• 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: Other,Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 419144
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 05220120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2022
• 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