MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO MISSION (US) 2.5/35; CORONARY DRUG-ELUTING STENT

Model Number	453968
Medical Device Problem Codes	Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
An orsiro mission drug-eluting stent system was selected for treatment of a moderately calcified lesion in the severely tortuous distal lcx.Despite pre dilatation, the lesion could not be crossed with the device.The lesion was re dilated with a larger nc balloon.Upon inspection and before re-inserting the stent, the proximal end of the stent was observed to be damaged.There was no resistance in removing the stent initially from the body.It is not certain what caused the damage.
Additional Manufacturer Narrative
Combination product: yes.
Additional Manufacturer Narrative
Combination product: yes.The returned product was subjected to a detailed technical analysis and the corresponding production documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.The technical investigation revealed that the stent is severely deformed at its proximal end, i.E., several stent struts are lifted, everted, and stretched.Microscopic inspection showed stent imprints on the exposed balloon surface, indicating that the bent struts were initially crimped on the balloon.Outside of the deformed zone the crimped diameter of the stent still complies with the specification.Review of the production 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.Based on the conducted investigations of the device being subject to this complaint, no material or manufacturing related root cause could be determined.It should be noted that the ifu clearly states not to re-insert the stent system as the stent and/or the delivery system may have been damaged during the initial attempt to cross the lesion or during the withdrawal.
Additional Manufacturer Narrative
Combination product: yes, corrected the initial reporter information.Reference capa# nc-24-004.The returned product was subjected to a detailed technical analysis and the corresponding production documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.The technical investigation revealed that the stent is severely deformed at its proximal end, i.E., several stent struts are lifted, everted, and stretched.Microscopic inspection showed stent imprints on the exposed balloon surface, indicating that the bent struts were initially crimped on the balloon.Outside of the deformed zone the crimped diameter of the stent still complies with the specification.Review of the production 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.Based on the conducted investigations of the device being subject to this complaint, no material or manufacturing related root cause could be determined.It should be noted that the ifu clearly states not to re-insert the stent system as the stent and/or the delivery system may have been damaged during the initial attempt to cross the lesion or during the withdrawal.

• Brand Name: ORSIRO MISSION (US) 2.5/35
• Common Device Name: 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: 18649608
• Report Number: 1028232-2024-00668
• Device Sequence Number: 17913323
• Product Code: NIQ
• UDI-Device Identifier: 07640130456242
• UDI-Public: (01)07640130456242(17)2509
• Combination Product (Y/N): Y
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: P170030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/16/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/06/2025
• Device Model Number: 453968
• Device Catalogue Number: 453968
• Device Lot Number: 08230893
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2024
• Supplement Date Received by Manufacturer: 02/28/2024; 10/16/2024
• Initial Report FDA Received Date: 02/06/2024
• Supplement Report FDA Received Date: 02/28/2024; 10/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown