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

Model Number 419114

Device Problem Failure to Advance (2524)

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

Event Date 03/15/2024

Event Type  malfunction  

Event Description

An orsiro mission drug-eluting stent system was selected for treatment of a moderately calcified lesion (stenosis degree: 99 percent) in the mildly tortuous mid lad.It is unknown if a pre-dilation was performed.It was a long lad lesion.A 2.75/35 orsiro mission was inserted.However, the plaque shifted to the distal side of the inserted orsiro mission and the stenosis did not resolve.Therefore, it was attempted to place a new 2.5/15 orsiro mission (complaint device) from distal, but it got caught in front of the previously placed 2.75/35 orsiro mission.The complaint device was removed from the body and then disposed at the facility.

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 passed all in-process and final inspections.Based on the conducted investigations, no material or manufacturing related root cause could be determined.The root cause for the reported event is most likely related to the patients anatomy (i.E.Previously implanted stent).

• 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: 19093111
• MDR Text Key: 340694222
• Report Number: 1028232-2024-01997
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 07640130441743
• UDI-Public: (01)07640130441743(17)2405
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: 419114
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 05223433
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/11/2024
• Initial Date FDA Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2022
• 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