MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO (US) 2.5/18; CORONARY DRUG-ELUTING STENT

Model Number	401748
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Thrombosis (2100)
Date of Event	10/15/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
An orsiro drug-eluting stent system was chosen to treat a calcified lesion with 85 percent stenosis degree.4 hours after implantation patient experienced chest pain.A stent thrombosis was detected.
Additional Manufacturer Narrative
Neither the complaint instrument nor the angiographic material was available for analysis.Therefore no technical investigation on the subject could be performed.The production documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.Review of the production documentation confirmed that the instrument was manufactured according to specifications and passed all in-process and final inspections.Based on the conducted investigations no manufacturing related root cause was determined.The physician determined that the stent thrombosis was not stent related since the ostial lesion was probably not completely covered.The root cause for the complaint event is therefore most likely related to external factors.

• Brand Name: ORSIRO (US) 2.5/18
• 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: 9255568
• Report Number: 1028232-2019-04759
• Device Sequence Number: 2054431
• Product Code: NIQ
• UDI-Device Identifier: 07640130439030
• UDI-Public: 07640130439030
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P170030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 10/18/2019

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: 11/08/2020
• Device Model Number: 401748
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 10185791
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/18/2019
• Supplement Date Received by Manufacturer: 12/10/2019
• Initial Report FDA Received Date: 10/30/2019
• Supplement Report FDA Received Date: 12/10/2019
• 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
• Patient Age: 70 YR