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

Model Number 419113

Device Problems Failure to Advance (2524); Material Deformation (2976)

Patient Problem Insufficient Information (4580)

Event Date 04/02/2024

Event Type  malfunction  

Manufacturer Narrative

Combination product: yes.Neither the affected product nor the angiographic material was returned.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 device was manufactured according to specifications and passed all in-process and final inspections.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.It should be noted that the ifu advice the user to pre-dilate the target lesion.Based on the conducted investigations, no material or manufacturing related root cause could be determined.It should be noted that the ifu advice the user to pre-dilate the target lesion.

Event Description

The orsiro mission drug-eluting stent system was selected for treatment of a mildly calcified lesion (stenosis degree: 50 percent) in the mildly tortuous part of the medial lad.Pre-dilatation was not performed.In a first step, an xience des was implanted in the medial lad number 7, after which the flow became poor.The complaint stent system was advanced towards the target lesion in the medial lad number 8, but the device got caught before reaching the lesion and was removed from the patients body.A stent deformation was confirmed outside of the patient.Eventually, the physician did not use a new stent and completed the procedure.Patient was discharged home.

• Brand Name: ORSIRO MISSION 2.25/15
• 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: 19168475
• MDR Text Key: 341479746
• Report Number: 1028232-2024-02212
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 07640130441736
• UDI-Public: (01)07640130441736(17)2404
• 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,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/25/2024
• Device Model Number: 419113
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 04220642
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2022
• 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