MAUDE Adverse Event Report: BIOTRONIK AG ORSIRO MISSION; CORONARY DRUG-ELUTING STENT

Model Number 4/13/140

Device Problems Mechanical Problem (1384); Activation Failure (3270)

Patient Problem Insufficient Information (4580)

Event Date 11/10/2021

Event Type  malfunction  

Event Description

Unable to deploy the orsito mission stent.When physician attempted to remove the undeployed stent, the stent was stripped off the delivery balloon and trapped on the filter wire.The filter was removed still expanded and it captured both stents.The filter wire and stents were pulled back to the right femoral artery sheath where the filter broke off the wire.The filter, deployed stent and undeployed stents were removed with the use of a en snare device.

• Brand Name: ORSIRO MISSION
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BIOTRONIK AG; 6024 sw jean rd. b4; lake oswego OR 97035
• MDR Report Key: 12915151
• MDR Text Key: 281595921
• Report Number: 12915151
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4/13/140
• Device Catalogue Number: 453936
• Device Lot Number: 05214840
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/23/2021
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 28105 DA
• Patient Sex: Male