MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO 2.25/22; CORONARY DRUG-ELUTING STENT

Model Number	364499
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/16/2019
Type of Reportable Event	Malfunction
Event or Problem Description
The orsiro drug-eluting stent system was selected to treat a severely calcified and tortuous lesion in the proximal lad.After pre-dilatation the target lesion could not be crossed.
Additional Manufacturer Narrative
The affected product was discarded at the hospital due to an infectious disease.Therefore no technical investigation on the device could be performed.The production documentation of the product was reviewed to determine whether there was any deviation that could account for this event.Further, the provided angiographic material was reviewed.The provided angiographic material was reviewed, but the actual complaint event is not visible.The presence of a severe calcification and tortuosity could be confirmed.Review of the production documentation of the complaint device confirmed 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, no material or manufacturing related root cause could be determined.Taking into account the physicians description of the intervention and target lesion as well as the appearance of the target vessel in the angiographic material, the root cause is most likely related to the patients anatomy.

• Brand Name: ORSIRO 2.25/22
• 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: 9569397
• Report Number: 1028232-2020-00114
• Device Sequence Number: 374563
• Product Code: NIQ
• UDI-Device Identifier: 07640130439085
• UDI-Public: 7640130439085
• 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): 01/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/04/2021
• Device Model Number: 364499
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 03195869
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/08/2020
• Supplement Date Received by Manufacturer: 03/11/2020
• Initial Report FDA Received Date: 01/09/2020
• Supplement Report FDA Received Date: 03/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1