MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO 2.5/9; CORONARY DRUG-ELUTING STENT

Model Number	401730
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/17/2019
Type of Reportable Event	Malfunction
Event or Problem Description
An orsiro drug-eluting stent was selected to treat a severely calcified lesion in a tortuous distal lad.Despite pre-dilatation the device could not cross the lesion.
Additional Manufacturer Narrative
The device was not returned for analysis, therefore no technical investigation of the stent or the delivery system could be performed.The manufacturing history of the product detailed above was reviewed to determine whether there was any deviation that could account for this event.In addition, the provided angiographic material was reviewed, but the complaint event was not visible.The review of the angiographic material did not lead to any further information regarding the nature of the complaint.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 or material related root cause could be identified.Since it was reported that also other stent systems failed to cross the lesion, the root cause is most likely related to patient anatomy.

• Brand Name: ORSIRO 2.5/9
• 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: 8644262
• Report Number: 1028232-2019-02149
• Device Sequence Number: 19335681
• Product Code: NIQ
• UDI-Device Identifier: 07640130438859
• UDI-Public: 07640130438859
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P170030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2019

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 Model Number: 401730
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 10184455
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/24/2019
• Supplement Date Received by Manufacturer: 07/24/2019
• Initial Report FDA Received Date: 05/27/2019
• Supplement Report FDA Received Date: 07/30/2019
• 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