MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO (US) 4.0/13; CORONARY DRUG-ELUTING STENT

Model Number	401740
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Combination product: yes.
Event or Problem Description
The stent was deployed in the ostium of the rca with approximately two-thirds of the stent located in the aorta outside the rca which was unsatisfactory.An attempt was made with guide and snare to remove the stent.On manipulation the stent was noted to be dislodged from the rca and could not be located anymore.
Additional Manufacturer Narrative
Combination product: yes.Neither the complaint instrument nor the angiographic material was available for analysis.Therefore, no technical investigation on the subject could be performed.The production documentation 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 was determined.It should be noted that, according to the ifu, orsiro is indicated for improving coronary luminal diameter in the native coronary arteries with a reference vessel diameter of 2.25 mm to 4.0 mm.Further, pre-dilatation of the lesion is mandatory.

• Brand Name: ORSIRO (US) 4.0/13
• 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: 11113471
• Report Number: 1028232-2021-00001
• Device Sequence Number: 11749852
• Product Code: NIQ
• UDI-Device Identifier: 07640130438958
• UDI-Public: 07640130438958
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: P170030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 12/16/2020

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: 07/14/2021
• Device Model Number: 401740
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 07190169
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/16/2020
• Supplement Date Received by Manufacturer: 02/11/2021
• Initial Report FDA Received Date: 01/04/2021
• Supplement Report FDA Received Date: 02/11/2021
• 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