MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO MISSION 3.0/15; CORONARY DRUG-ELUTING STENT

Model Number 419116

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Foreign Body In Patient (2687); Insufficient Information (4580)

Event Date 01/10/2024

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, 99 percent stenosis degree in the moderately tortuous ostial rca.An attempt was made to deliver the orsiro mission stent to the lesion, but delivery was difficult due to the presence of an artificial valve after tavi and calcification.Therefore, the stent was pulled back together with the catheter, but the stent was not on the balloon anymore.During subsequent angiography, the stent appeared to be stuck in the artificial valve.

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 instrument was manufactured according to specifications and passed all in-process and final inspections.As a part of final inspection every stent system undergoes visual inspection to ensure correct embedding and homogeneous crimping of the stent.Further, the stent outer diameter and the stent retention force of a defined amount of samples is tested from every lot.Based on the conducted investigations, no material or manufacturing related root cause could be determined.Considering the event description provided, the most probable root cause for the reported event is related to the patients anatomy (i.E.The stent got stuck in the artificial valve).

• Brand Name: ORSIRO MISSION 3.0/15
• 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: 18627298
• MDR Text Key: 334556636
• Report Number: 1028232-2024-00622
• Device Sequence Number: 1
• Product Code: NIQ
• 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: 02/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 419116
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 06225953
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2022
• 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