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 02/12/2021

Event Type  Injury  

Manufacturer Narrative

Combination product: yes.

Event Description

In context of a dapt study, an orsiro mission drug-eluting stent was implanted.4 days after the index procedure patient suffered from chest pain.An electrocardiogram was performed which revealed an anterior shift.Patient underwent a cag which showed a stent thrombosis in the index lesion.

Manufacturer Narrative

Combination product: yes.Four days after the index procedure patient suffered from chest pain.An electrocardiogram was performed which revealed acute coronary syndrome with st segment elevation.Coronary angioplasty revealed acute intra-stent thrombotic occlusion of the previously implanted stent.Finally, the attempt to remove the blockage was not successful due to a semi-recent thrombosis not allowing passage of the guidewire.Decision for continuation of medical treatment.The device itself was not returned and could therefore not be subjected to a technical investigation.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.

• 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
• MDR Report Key: 11595548
• MDR Text Key: 243144906
• Report Number: 1028232-2021-01539
• 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
• Report Date: 03/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/07/2022
• Device Model Number: 419115
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 12190322
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/30/2021
• Initial Date FDA Received: 03/31/2021
• Supplement Dates Manufacturer Received: 09/27/2021
• Supplement Dates FDA Received: 09/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention