MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO (US) 2.25/9; CORONARY DRUG-ELUTING STENT

Model Number	401729
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/10/2019
Type of Reportable Event	Malfunction
Event or Problem Description
An orsiro drug-eluting stent system was chosen to treat a severely calcified lesion in an extreme tortuous vessel.During procedure the stent dislodged.No lot number was provided.
Additional Manufacturer Narrative
Neither the complaint instrument nor the lot number of the device was provided for analysis.Therefore no technical investigation on the subject could be performed.The manufacturing history of the last three orsiro 2.25/9 product lots that were delivered to the hospital prior to the reported event date were reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.Review of the three production documentations confirmed that the instruments were manufactured according to specifications and passed all in-process and final inspections.The final root cause is most likely related to patient anatomy.

• Brand Name: ORSIRO (US) 2.25/9
• 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: 8746028
• Report Number: 1028232-2019-02628
• Device Sequence Number: 2566194
• Product Code: NIQ
• UDI-Device Identifier: 07640130438842
• UDI-Public: 07640130438842
• 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,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2019

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: 401729
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/13/2019
• Supplement Date Received by Manufacturer: 08/15/2019
• Initial Report FDA Received Date: 06/28/2019
• Supplement Report FDA Received Date: 08/15/2019
• 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