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

Model Number	401743
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	06/01/2020
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BIOTRONIK AG, BUELACH, SWITZERLAND; ackerstrasse 6; buelach CH-81 80; CH CH-8180
• MDR Report Key: 10393632
• Report Number: 1028232-2020-03355
• Device Sequence Number: 1712311
• Product Code: NIQ
• UDI-Device Identifier: 07640130438989
• UDI-Public: 07640130438989
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P170030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,study
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 07/13/2020
• Supplement Date Received by Manufacturer: 07/13/2020
• Initial Report FDA Received Date: 08/11/2020
• Supplement Report FDA Received Date: 08/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 63 YR