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

Model Number	401750
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/08/2019
Type of Reportable Event	Malfunction
Event or Problem Description
An orsiro drug-eluting stent system was chosen to treat a calcified lesion (>90 percent stenosis degree) in a tortuous part of the rca.The device could not be advanced.After withdrawal it was detected that the stent was damaged.A teleflex 6f guideliner was used during procedure.
Additional Manufacturer Narrative
The returned product was subjected to a technical analysis and the corresponding production documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for this event.The technical investigation of the returned instrument revealed that the stent is deformed at its proximal end.The balloon is well folded and shows no signs of inflation.Microscopic analysis revealed stent imprints on the exposed balloon surface indicating that the bent struts were initially crimped on the balloon.Review of the production documentation confirmed that the instrument was manufactured according to specifications and passed all in-process and final inspections.As a part of final inspection every stent system undergoes visual inspection to ensure correct embedding and homogeneous crimping of the stent.Based on the conducted investigations, no manufacturing or material related root cause could be determined.The root cause is most likely related to external factors during the procedure.

• 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: 8940731
• Report Number: 1028232-2019-03705
• Device Sequence Number: 16668880
• 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): 08/09/2019

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 Expiration Date: 11/13/2020
• Device Model Number: 401750
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 11180437
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2019
• Initial Date Received by Manufacturer: 08/09/2019
• Supplement Date Received by Manufacturer: 10/23/2019
• Initial Report FDA Received Date: 08/28/2019
• Supplement Report FDA Received Date: 10/23/2019
• 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
• Patient Age: 60 YR