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

Model Number 3.0/30/140

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem Insufficient Information (4580)

Event Date 02/08/2022

Event Type  malfunction  

Event Description

During use of the device, it was discovered while balloon was in the patient, no stent.It was first assumed the stent fell off balloon while in the patient when taking stylet out of balloon stent.Md looked for an emboli occurrence, but no embolization occurred.Looked in plastic casing and found stylet with stent on it.

• Brand Name: ORSIRO
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BIOTRONIK AG; 6024 jean rd; lake oswego OR 97035
• MDR Report Key: 13719993
• MDR Text Key: 286921433
• Report Number: 13719993
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 03/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 3.0/30/140
• Device Catalogue Number: 401768
• Device Lot Number: 6216270
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/03/2022
• Date Report to Manufacturer: 03/10/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1