MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO 3.5/35; CORONARY DRUG-ELUTING STENT

Model Number	391018
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	03/07/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2021, the patient admitted with st elevated ami (distal rca) and successfully treated with orsiro des (timi iii flow post-operative).Dapt was initiated.6 days later, patient developed bradycardia and avb.During control angiography a total occlusion was observed proximal to the stent.Poba was done and dapt medication was changed, and the patient was discharged.The physician commented that this event occurred more likely due to drug dosage timing rather than device related issue.
Additional Manufacturer Narrative
Six days after the successful index procedure coronary angiography revealed total occlusion at the proximal side of the previously implanted orsiro stent which was treated successfully with balloon angioplasty.The provided clinical information was insufficient to establish whether a device deficiency contributed to this event.However, review of the product release documentation confirmed that the device was manufactured according to specifications and fulfilled all the requirements of in-process and final inspection.Based on the provided documentation no device deficiency or manufacturing related root cause could be identified.The treating physician commented that the reported occurrence is more likely due to drug dosage timing rather than device-related issues.Other des revealed the same phenomenon.After entering the cathlab, heparin was started, but due to preparation to the device time was very fast, so it is possible that the drug was not effective until des implantation.

• Brand Name: ORSIRO 3.5/35
• 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: 12334284
• Report Number: 1028232-2021-04633
• Device Sequence Number: 4713203
• Product Code: NIQ
• UDI-Device Identifier: 07640130439399
• UDI-Public: 07640130439399
• Combination Product (Y/N): N
• 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,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2021

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: 04/17/2022
• Device Model Number: 391018
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 03204787
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/17/2021
• Supplement Date Received by Manufacturer: 09/09/2021
• Initial Report FDA Received Date: 08/17/2021
• Supplement Report FDA Received Date: 09/09/2021
• 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