MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO MISSION 2.5/22; CORONARY DRUG-ELUTING STENT

Model Number 419126

Device Problem Failure to Advance (2524)

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

Event Date 02/04/2024

Event Type  malfunction  

Manufacturer Narrative

Combination product: yes.Neither the affected device 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 fulfilled all the requirements of in-process and final inspection.Based on the conducted investigations of the device being subject to this complaint, no material or manufacturing related root cause could be determined.Considering the physicians description, the root cause for the complaint event is most likely related to the patients anatomy (i.E.Calcification and severe tortuosity).

Event Description

An orsiro mission drug-eluting stent system was selected for treatment of a moderately calcified lesion (99 percent stenosis degree) in a severely tortuous part of the mid lad.The lesion was pre-dilated, and the affected device was introduced into the patients body but could not pass the lesion due to calcification and severe tortuosity.The procedure was completed using a rotablator and dcb.The stent was discarded at the facility because the patient had an infectious disease.

• Brand Name: ORSIRO MISSION 2.5/22
• 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: 18899274
• MDR Text Key: 337643203
• Report Number: 1028232-2024-01409
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 07640130441866
• UDI-Public: (01)07640130441866(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: 03/13/2024

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
• Device Operator: Health Professional
• Device Model Number: 419126
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 06225589
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2024
• Initial Date FDA Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2022
• 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