MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO MISSION 3.0/26; CORONARY DRUG-ELUTING STENT

Model Number 419134

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

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

Event Date 03/19/2023

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.Based on the conducted investigations, no material or manufacturing related root cause could be determined.

Event Description

An orsiro mission drug-eluting stent systems were selected for treatment of a severely calcified lesion (stenosis degree: 90 percent) in the severely tortuous mid lcx.Despite pre-poba, the lesion could not be crossed with the device.The stent was removed from the patient and checked.The check showed that the stent was deformed.Another orsiro mission was used.

• Brand Name: ORSIRO MISSION 3.0/26
• 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: 19093107
• MDR Text Key: 340613046
• Report Number: 1028232-2024-01998
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 07640130441941
• UDI-Public: (01)07640130441941(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
• Report Date: 04/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 419134
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 06225593
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2022
• 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