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

Model Number 404674

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Cardiac Arrest (1762)

Event Date 03/31/2022

Event Type  Death  

Manufacturer Narrative

Combination product: yes.

Event 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the orsiro across the proximal portion of the lesion, the stent was not able to be advanced any further.Stent was withdrawn.Stent became stripped off the balloon.Several smaller balloons were then used to go back into the stent to try to deploy it, and it did finally deploy.At this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
• Type of Device: 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
• MDR Text Key: 290070682
• Report Number: 1028232-2022-02113
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 07640130439436
• UDI-Public: 07640130439436
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P170030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 05/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Sex: Male