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

Model Number 2.75/30/140

Device Problems Collapse (1099); Material Deformation (2976)

Patient Problem Insufficient Information (4580)

Event Date 02/04/2021

Event Type  malfunction  

Event Description

Stent did not cross lad lesion.When stent was removed, it was noticed that the sides of the stent were collapsed and deformed at the proximal end.

• Brand Name: ORSIRO
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BIOTRONIK INC.; 6024 jean road; lake oswego OR 97035
• MDR Report Key: 11515154
• MDR Text Key: 240625419
• Report Number: 11515154
• 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: 03/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2.75/30/140
• Device Catalogue Number: REF # 401767
• Device Lot Number: 06200283
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/15/2021
• Event Location: Hospital
• Date Report to Manufacturer: 03/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 24455 DA
• Patient Weight: 89