MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO 3.5/9; CORONARY DRUG-ELUTING STENT

Model Number	401733
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
The orsiro drug-eluting stent system could not pass the calcified lesion.No more information available.
Additional Manufacturer Narrative
The returned instrument was subjected to a detailed technical analysis and the corresponding production documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.The technical investigation revealed that the orsiro stent is neither deformed nor damaged.The stent is properly crimped in between the two radiopaque markers.The balloon is well folded and shows no signs of inflation.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 or material related root cause could be determined.

• Brand Name: ORSIRO 3.5/9
• 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: 8746041
• Report Number: 1028232-2019-02623
• Device Sequence Number: 11404511
• Product Code: NIQ
• UDI-Device Identifier: 07640130438880
• UDI-Public: 07640130438880
• 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): 06/11/2019

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: 401733
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 10182342
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2019
• Initial Date Received by Manufacturer: 06/11/2019
• Supplement Date Received by Manufacturer: 08/27/2019
• Initial Report FDA Received Date: 06/28/2019
• 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