MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO (US) 2.5/30; CORONARY DRUG-ELUTING STENT

Model Number	401766
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2021
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.During preparation it was detected that no stent was on the balloon.Another device was used to complete the intervention.
Additional Manufacturer Narrative
Combination product: yes.This was originally reported on the incorrect size and lot number.This report is being closed and the correct size is being reported on mdr-1028232-2021-05778.

• Brand Name: ORSIRO (US) 2.5/30
• 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: 12631219
• Report Number: 1028232-2021-05694
• Device Sequence Number: 14310507
• Product Code: NIQ
• UDI-Device Identifier: 07640130439214
• UDI-Public: 07640130439214
• 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): 09/30/2021

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: 05/17/2023
• Device Model Number: 401766
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 04213447
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/30/2021
• Supplement Date Received by Manufacturer: 10/18/2021
• Initial Report FDA Received Date: 10/14/2021
• Supplement Report FDA Received Date: 10/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1