MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO MISSION 3.0/18; CORONARY DRUG-ELUTING STENT

Model Number 419122

Device Problem Structural Problem (2506)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/26/2020

Event Type  Injury  

Manufacturer Narrative

Combination product: yes.

Event Description

An orsiro mission drug-eluting stent system was selected for treatment of the lad.28 days post-procedure during a planned follow-up examination a malposition of the stent was detected.The patient presented no clinical symptoms.A target lesion revascularization was performed.Lot number and size is not available at this time.

Manufacturer Narrative

Combination product: yes.Lot number and device size added.28 days post-procedure during a planned follow-up examination a malposition of the stent was detected.During the scheduled intervention, a thrombus in the stent was detected with malposition of the stent struts.However, the clinical events committee adjudicated this event as a clinically driven tlr due to insufficient stent apposition with unlikely relationship to the device.The implanted stent could not be subjected to a technical investigation.However, the provided clinical information and the device production documentation were reviewed to establish whether a device deficiency and a deviation from the manufacturing process could be the cause for this event.Review of the product release documentation for the product described above confirmed that the device was manufactured according to specifications and fulfilled all the requirements of in-process and final inspection.Based on the reviewed documentation and the conducted investigation no device deficiency or manufacturing related root cause could be identified.

• Brand Name: ORSIRO MISSION 3.0/18
• 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: 11690682
• MDR Text Key: 246223787
• Report Number: 1028232-2021-01919
• 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: 04/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 419122
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 10195995
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention