MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO MISSION (US) 2.25/30; CORONARY DRUG-ELUTING STENT

Model Number	453961
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2021
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 a pre-dilated lesion.When introducing the device into the body, the back end of the shaft bent.Resistance was felt when the device was advanced deeper into the vessel.By pushing harder, the kink got worse.While removing the stent system from the guide, the back end of the shaft broke apart.
Additional Manufacturer Narrative
Combination product: yes.The returned instrument was subjected to a detailed technical analysis and the corresponding product release documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.The technical investigation of the returned device revealed that the hypotube has fractured about 17 cm distal to the distal end of the kink protector.Several kinks were observed along both sides of the fracture site.The cross-section of the hypotube at the fracture sites is no longer circular but compressed into an ellipse and the polymer coating is plastically deformed.The findings indicate that the hypotube most probably fractured as a result of significant bending outside of the patients body.Review of the product release 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.The root cause for the complaint event is most likely related to the handling of the device.

• Brand Name: ORSIRO MISSION (US) 2.25/30
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BIOTRONIK AG, BUELACH, SWITZERLAND; ackerstrasse 6; buelach CH-81 80; CH CH-8180
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 12741002
• Report Number: 1028232-2021-05959
• Device Sequence Number: 19836599
• Product Code: NIQ
• UDI-Device Identifier: 07640130456174
• UDI-Public: 07640130456174
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: P170030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2021

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: 07/16/2023
• Device Model Number: 453961
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 05214864
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2021
• Supplement Date Received by Manufacturer: 11/22/2021
• Initial Report FDA Received Date: 11/02/2021
• Supplement Report FDA Received Date: 11/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 88 YR
• Patient Sex: Male