MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO 2.75/18; CORONARY DRUG-ELUTING STENT

Model Number	364489
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Bradycardia (1751); Thrombosis/Thrombus (4440)
Date of Event	04/30/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Combination product: yes.
Event or Problem Description
Three orsiro drug-eluting stent systems were selected for treatment of a lesion (80-90 percent stenosis degree) in the distal rca/om.On (b)(6) 2021 the lesion was treated amongst others with an orsiro 2.75/18 with good results.The next day the patient went into vasovagal attack with bradycardia and hypotension.A control pci was conducted and multiple thrombosis were detected.Several aspirations were done with very good result.An intraaortic balloon pump (iabp) was implanted.The other two orsiro stents are reported separately.
Additional Manufacturer Narrative
Combination product: yes according to the case description the patient underwent successfully a percutaneous coronary intervention with 3 orsiro drug-eluting stents to the rca and om.The day after the patient went into vasovagal attack with bradycardia and hypotension, the coronary angiography revealed a thrombotic occlusion of the vessel segments treated the day before.The device itself was not returned to biotronik and could therefore not be subjected to a technical investigation.However, the provided operative report and the angiographic material were reviewed to identify a potential technical complication or device malfunction.Further the production documentation of both products was reviewed to establish whether a deviation from the manufacturing process could be the cause for this event.Review of the production documentation for the product detailed above confirmed that both devices were manufactured according to specifications and fulfilled all the requirements of in-process and final inspection.Based on the reviewed documentation and the conducted investigation no device deficiency or manufacturing related root cause could be identified.

• Brand Name: ORSIRO 2.75/18
• 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: 11848277
• Report Number: 1028232-2021-02725
• Device Sequence Number: 3149401
• Product Code: NIQ
• UDI-Device Identifier: 07640130439047
• UDI-Public: 7640130439047
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• PMA/510(K) Number: P170030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/21/2022
• Device Model Number: 364489
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 08204114
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/19/2021
• Supplement Date Received by Manufacturer: 07/14/2021
• Initial Report FDA Received Date: 05/19/2021
• Supplement Report FDA Received Date: 07/14/2021
• 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; Required Intervention