MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO (US) 2.25/15; CORONARY DRUG-ELUTING STENT

Model Number	401741
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Combination product: yes.
Event or Problem Description
An orsiro drug-eluting stent system was selected for treatment of the lcx.During withdrawal of the device through guidezilla extension catheter the shaft separated from tip with stent.The stent was retrieved from guidezilla.
Additional Manufacturer Narrative
Combination product: yes.The complaint instrument was not returned for analysis.Therefore, no technical investigation on the subject could be performed.Only two fragments of the guiding extension catheter which was used in the intervention were returned for technical investigation.All fragments were inspected, and it could be verified that the dislodged stent, its fragments or parts of the delivery system was not found inside of the fragments.Review of the production documentation verified that the instruments were manufactured according to specifications and fulfilled all the requirements of in-process and final inspection.During final inspection, every stent system undergoes visual inspection to ensure correct stent embedding and homogeneous crimping of the stent.Further, the stent outer diameter is verified to 100 percent, the stent retention force and the tensile strength of the delivery system of a defined amount of samples is tested from every lot.Based on the conducted investigations of the device being subject to this complaint, no material or manufacturing related root cause could be determined.

• Brand Name: ORSIRO (US) 2.25/15
• 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: 10601329
• Report Number: 1028232-2020-04148
• Device Sequence Number: 3158606
• Product Code: NIQ
• UDI-Device Identifier: 07640130438965
• UDI-Public: 07640130438965
• 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): 09/08/2020

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: 06/13/2021
• Device Model Number: 401741
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 05196220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2020
• Initial Date Received by Manufacturer: 09/08/2020
• Supplement Date Received by Manufacturer: 11/24/2020
• Initial Report FDA Received Date: 09/29/2020
• Supplement Report FDA Received Date: 12/01/2020
• 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