MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO MISSION (US) 2.75/30; CORONARY DRUG-ELUTING STENT

Model Number 453963

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Failure of Implant (1924)

Event Date 03/18/2022

Event Type  malfunction  

Manufacturer Narrative

Combination product: yes the returned product was subjected to a detailed technical analysis and the corresponding product release documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for this event.The technical investigation revealed that the balloon is well folded and shows no signs of inflation but contrast medium residue was observed in balloon- and inflation lumen which implies application of negative pressure.Microscopic inspection showed stent imprints on the exposed balloon surface, indicating that the stent was properly crimped in between the two radiopaque markers at the time of delivery.The stent was not returned for analysis.Review of the product release documentation confirmed that the instrument 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.Further, the stent outer diameter is verified to 100 percent and the stent retention force of a defined amount of samples is tested from every lot.Based on the conducted investigations of the device being subject to this complaint, no material or manufacturing related root cause was determined.The root cause for the complaint event is most likely related to the handling during the procedure, i.E.Application of negative pressure prior to placement of the stent across the target lesion which is warned against in the ifu.

Event Description

An orsiro mission drug-eluting stent system was selected for treatment.After wiring and pre-dilatation, the lesion in a vein graft was successfully crossed.While pulling the device back to re-position, a slight catch was felt.At this point the device would no longer advance.The device was withdrawn, and it was detected that the stent was dislodged.The equipment was left inside the body and the patient was transferred to surgery.

• Brand Name: ORSIRO MISSION (US) 2.75/30
• 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: 14103640
• MDR Text Key: 289254946
• Report Number: 1028232-2022-01895
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 07640130456198
• UDI-Public: 07640130456198
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P170030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/20/2023
• Device Model Number: 453963
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 12211421
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2021
• 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
• Patient Outcome(s): Hospitalization