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 (2100)
Date of Event	05/04/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
An orsiro drug-eluting stent system was chosen for treatment of high stenosis lesion in the rca.7.5 weeks after primary intervention the patient fell while working and was transferred to hospital.A stent thrombosis was detected.Pci was done.It was stated by the physician that antiplatelet therapy might not have been effective and therefore medication was changed.5.5 weeks later again a thrombosis was detected during follow-up examination.Since the change of antiplatelet medication did not show the expected result it was stated that it might be a patient related issue.
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 reported that the first stent thrombosis may be related to weak antiplatelet activity.The cause of the second stent thrombosis remains unknown since switching from prasugrel to clopidogrel showed no effect.

• 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: 10188490
• Report Number: 1028232-2020-02569
• Device Sequence Number: 3298328
• Product Code: NIQ
• UDI-Device Identifier: 07640130439399
• UDI-Public: 07640130439399
• Combination Product (Y/N): N
• 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): 06/23/2020

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: 09/24/2020
• Device Model Number: 391018
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 09181409
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/23/2020
• Supplement Date Received by Manufacturer: 07/22/2020
• Initial Report FDA Received Date: 06/24/2020
• Supplement Report FDA Received Date: 07/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1