MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO (US) 2.75/40; CORONARY DRUG-ELUTING STENT

Model Number	404674
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	03/31/2022
Type of Reportable Event	Death
Additional Manufacturer Narrative
Combination product: yes.
Event or Problem Description
The patient was admitted for non-st-elevation myocardial infraction with severe multi-vessel coronary artery disease.An orsiro drug-eluting stent system was selected for treatment.During the procedure, while the provider was attempting to advance the orsiro across the proximal portion of the lesion, the stent was not able to be advanced any further.Stent was withdrawn.Stent became stripped off the balloon.Several smaller balloons were then used to go back into the stent to try to deploy it, and it did finally deploy.At this time the patients condition deteriorated.Code arrest and expired.This event was reported by hospital under medwatch ref.(b)(4).

• Brand Name: ORSIRO (US) 2.75/40
• 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: 14207940
• Report Number: 1028232-2022-02113
• Device Sequence Number: 1804592
• Product Code: NIQ
• UDI-Device Identifier: 07640130439436
• UDI-Public: 07640130439436
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: P170030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 04/14/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/12/2023
• Device Model Number: 404674
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 02214585
• 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: 04/14/2022
• Supplement Date Received by Manufacturer: 05/19/2022
• Initial Report FDA Received Date: 04/26/2022
• Supplement Report FDA Received Date: 05/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2021
• 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: Male