MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO MISSION 3.5/22; CORONARY DRUG-ELUTING STENT

Model Number 419129

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/07/2024

Event Type  malfunction  

Manufacturer Narrative

Combination product: yes.

Event Description

An orsiro mission drug-eluting stent system was selected for treatment of a severely calcified lesion (stenosis degree: 99 percent) in the moderately tortuous distal rca.Pre-dilatation was not performed.When approaching the rca lesion and due to the severe calcification and stenosis, resistance was felt when the orsiro mission was pushed into the lesion.Once the catheter was pulled back, there was resistance due to the hangnail (deformation), and its use was discontinued.Afterwards, a dilatation was performed, and another stent was used to complete the procedure.

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.Based on the conducted investigations, no material or manufacturing related root cause could be determined.It should be noted that the ifu states to pre-dilate the lesion using a recommended balloon diameter that is 0.5 mm smaller than the reference vessel diameter and the length equal to or shorter than the target lesion length.

• Brand Name: ORSIRO MISSION 3.5/22
• 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: 18939943
• MDR Text Key: 338250020
• Report Number: 1028232-2024-01534
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 07640130441897
• UDI-Public: (01)07640130441897(17)2407
• 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,Followup
• Report Date: 04/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 419129
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 06222932
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2022
• 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