MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO (US) 2.75/15; CORONARY DRUG-ELUTING STENT

Model Number 401743

Device Problem Use of Device Problem (1670)

Patient Problem Vascular Dissection (3160)

Event Date 06/01/2020

Event Type  Injury  

Event Description

An orsiro drug-eluting stent system was chosen for treatment.Patient underwent a heart catheterization due to an nstemi.The stent was placed to om1, culprit lesion.A small dissection was noted after implantation.Another osiro stent was placed to dissected area distal to initial stent, however overlapping.Patient was stable throughout the procedure and overnight and was discharged home.

Manufacturer Narrative

17-aug-2020 - this report was opened in error.The lot number is incorrect.The correct lot number is 05193862, which was reported on mdr-1028232-2020-03248.Closing this report.

• Brand Name: ORSIRO (US) 2.75/15
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BIOTRONIK AG, BUELACH, SWITZERLAND; ackerstrasse 6; buelach CH-81 80; CH CH-8180
• MDR Report Key: 10393632
• MDR Text Key: 202507085
• Report Number: 1028232-2020-03355
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 07640130438989
• UDI-Public: 07640130438989
• Combination Product (y/n): N
• PMA/PMN Number: P170030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,study
• Type of Report: Initial,Followup
• Report Date: 07/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/02/2020
• Device Model Number: 401743
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 11184278
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/13/2020
• Initial Date FDA Received: 08/11/2020
• Supplement Dates Manufacturer Received: 07/13/2020
• Supplement Dates FDA Received: 08/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 63 YR