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

Model Number 2.5/30/140

Device Problems Break (1069); Device Slipped (1584)

Patient Problem Insufficient Information (4580)

Event Date 01/11/2021

Event Type  malfunction  

Event Description

Biotronik orsiro stent had shifted down the balloon and the front end of the stent was severely damaged.

• Brand Name: ORSIRO
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BIOTRONIK AG; 6024 jean road; lake oswego OR 97035
• MDR Report Key: 11250777
• MDR Text Key: 229332507
• Report Number: 11250777
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2.5/30/140
• Device Catalogue Number: 401766
• Device Lot Number: 05202578
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/21/2021
• Event Location: Hospital
• Date Report to Manufacturer: 01/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25550 DA