MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO 2.25/18; CORONARY DRUG-ELUTING STENT

Model Number	364487
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2021
Type of Reportable Event	Malfunction
Event or Problem Description
An orsiro drug-eluting stent system was selected for treatment of a moderately calcified lesion (98 percent stenosis degree) in the moderately tortuous proximal cx.After pre-dilatation, the attempt to deliver the stent was unsuccessful.When the device was removed, the proximal part of the stent was damaged.
Additional Manufacturer Narrative
Combination product: yes.
Additional Manufacturer Narrative
Combination product: yes.Asset, model name and model number are incorrect.New report opened, mdr-1028232-2021-06784.Closing this report.

• Brand Name: ORSIRO 2.25/18
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BIOTRONIK AG, BUELACH, SWITZERLAND; ackerstrasse 6; buelach CH-81 80; CH CH-8180
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 12975404
• Report Number: 1028232-2021-06682
• Device Sequence Number: 11982686
• Product Code: NIQ
• UDI-Device Identifier: 07640130439023
• UDI-Public: 7640130439023
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: P170030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/15/2023
• Device Model Number: 364487
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 05214190
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2021
• Supplement Date Received by Manufacturer: 12/15/2021
• Initial Report FDA Received Date: 12/10/2021
• Supplement Report FDA Received Date: 12/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown