MAUDE Adverse Event Report: BIOTRONIK INC. OSIRO STENT; CORONARY DRUG-ELUTING STENT

Model Number 453937

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 05/26/2022

Event Type  malfunction  

Event Description

Stent came loose before expanding the balloon.Fda safety report id # (b)(4).

• Brand Name: OSIRO STENT
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BIOTRONIK INC.; lake oswego OR 97035
• MDR Report Key: 14575324
• MDR Text Key: 293286464
• Report Number: MW5110033
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/23/2023
• Device Model Number: 453937
• Device Lot Number: 11217425
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female