MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO (US) 3.0/15; CORONARY DRUG-ELUTING STENT

Model Number	401744
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Combination product: yes.
Event or Problem Description
An orsiro drug-eluting stent system was selected for treatment.The lesion could not be crossed with the device and was removed from the patients body to balloon the vessel again.Before reinserting, the delivery system was wiped down and the stent came off the balloon outside the patients body.
Additional Manufacturer Narrative
Combination product: yes.Incorrect lot number was reported.Closing this report and opened mdr-1028232-2021-03367 with the correct lot number.

• Brand Name: ORSIRO (US) 3.0/15
• 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: 11889547
• Report Number: 1028232-2021-02877
• Device Sequence Number: 19179890
• Product Code: NIQ
• UDI-Device Identifier: 07640130438996
• UDI-Public: 07640130438996
• 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: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2021

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: 09/10/2022
• Device Model Number: 401744
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 08204139
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 05/17/2021
• Initial Date Received by Manufacturer: 05/11/2021
• Supplement Date Received by Manufacturer: 06/16/2021
• Initial Report FDA Received Date: 05/26/2021
• Supplement Report FDA Received Date: 06/16/2021
• 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