MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO 3.5/18; CORONARY DRUG-ELUTING STENT

Model Number	364491
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Thrombosis (2100)
Date of Event	03/22/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
The orsiro drug-eluting stent system was selected for use.The orsiro was initially deployed in the distal rca due to an in-stent restenosis during the index procedure on (b)(6) 2016.On (b)(6) 2019 the patient returned with symptoms, an angio was done and an in-stent thrombosis detected.
Additional Manufacturer Narrative
The device was not provided for investigation.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.In addition, the provided angiographic material was reviewed.The provided angiographic material was reviewed by a medical affairs expert.The images of the baseline procedure show the pre-dilatation of the target lesion as well as the inflation of the complaint stent.In the angiographic material of the follow-up procedure the stent thrombosis is visible.The physician performs balloon dilatations and thrombus aspiration.Review of the production documentation for the product detailed above verified that the instrument was manufactured according to specifications and fulfilled all the requirements of in-process and final inspection.Based on the conducted investigations no manufacturing related root cause could be identified.There are number of factors contributing to stent thrombosis.In the underlying case the physician noted that the in-stent thrombosis may have occurred due to insufficient stent expansion or antiplatelet drug resistance.

• Brand Name: ORSIRO 3.5/18
• 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: 9504159
• Report Number: 1028232-2019-05693
• Device Sequence Number: 14198526
• Product Code: NIQ
• UDI-Device Identifier: 07640130439061
• UDI-Public: 7640130439061
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2019

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: 07/23/2017
• Device Model Number: 364491
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 06157430
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/19/2019
• Supplement Date Received by Manufacturer: 03/30/2020
• Initial Report FDA Received Date: 12/20/2019
• Supplement Report FDA Received Date: 03/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1