MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO (US) 3.0/18; CORONARY DRUG-ELUTING STENT

Model Number	401750
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Death (1802)
Date of Event	11/08/2019
Type of Reportable Event	Death
Event or Problem Description
It was reported that an orsiro drug-eluting stent system was implanted in a stemi patient with a total occlusion of the rca.A t.V.P.(transvenous pacing) was placed due to arrhythmia episodes prior to procedure.The patient had several arrhythmia episodes during the intervention.Angiographic films showed that post-procedure the stent was open and the artery had good blood flow.Approximately 1 hour post-procedure, the patient went into ventricular tachycardia (vt) and was not able to be resuscitated.Preliminary findings indicated that the adverse event was not stent related.The circumstances of death are still unclear.An autopsy was ordered, however no results have been reported.No lot number was provided.
Additional Manufacturer Narrative
Neither the complaint instrument nor the angiographic material was returned 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 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 of the device being subject to this complaint, we can confirm that no product failure could be determined.The circumstances of patients death remain unclear.An autopsy was ordered, but to-date no results have been reported.Preliminary findings indicated that the adverse event was not stent related.

• Brand Name: ORSIRO (US) 3.0/18
• 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: 9438598
• Report Number: 1028232-2019-05468
• Device Sequence Number: 11339266
• Product Code: NIQ
• UDI-Device Identifier: 07640130439054
• UDI-Public: 07640130439054
• 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): 11/13/2019

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: 06/25/2021
• Device Model Number: 401750
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 06190863
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/13/2019
• Supplement Date Received by Manufacturer: 02/06/2020
• Initial Report FDA Received Date: 12/09/2019
• Supplement Report FDA Received Date: 02/06/2020
• 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: Death