MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO (US) 3.5/26; CORONARY DRUG-ELUTING STENT

Model Number	401763
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/16/2019
Type of Reportable Event	Malfunction
Event or Problem Description
An orsio drug-eluting stent system was chosen to treat a severe calcified lesion (100% stenosis degree) in a tortuous rca.The device could not pass the undilated lesion.
Additional Manufacturer Narrative
Neither the complaint instrument nor the angiographic material was provided for analysis.Therefore no technical investigation on the subject could be performed.The manufacturing history 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 could be determined.It should be noted that according to the ifu pre-dilatation of the lesion is mandatory.

• Brand Name: ORSIRO (US) 3.5/26
• 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: 8750625
• Report Number: 1028232-2019-02681
• Device Sequence Number: 11273351
• Product Code: NIQ
• UDI-Device Identifier: 07640130439184
• UDI-Public: 07640130439184
• 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): 06/17/2019

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: 401763
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 10184459
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/17/2019
• Supplement Date Received by Manufacturer: 08/28/2019
• Initial Report FDA Received Date: 07/01/2019
• Supplement Report FDA Received Date: 08/29/2019
• 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