MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO MISSION 2.5/15; CORONARY DRUG-ELUTING STENT

Model Number 419114

Device Problem Fracture (1260)

Patient Problem Insufficient Information (4580)

Event Date 04/19/2023

Event Type  malfunction  

Event Description

An orsiro mission drug-eluting stent system was selected for treatment.During procedure after 2 turns the device broke.Further information is requested.

Manufacturer Narrative

Combination product: yes.

Manufacturer Narrative

Combination product: yes.The returned product 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 this event.The technical investigation revealed that the hypotube has fractured at the distal end of the kink protector.The cross-section of the hypotube at the fracture sites is no longer circular but compressed into an ellipse and appears torqued.The polymer coating is plastically deformed.The hypotube further shows several mild kinks over its entire length.The findings indicate that the hypotube most probably fractured as a result of significant torquing 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 during the procedure.It should be noted that the corresponding ifu advises the user to not torque the catheter more than one full turn.

• Brand Name: ORSIRO MISSION 2.5/15
• Type of Device: 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: 16936581
• MDR Text Key: 315269750
• Report Number: 1028232-2023-02464
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 07640130441743
• UDI-Public: (01)07640130441743(17)2406
• Combination Product (y/n): Y
• Reporter Country Code: CH
• PMA/PMN Number: P170030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 419114
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 05224340
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1