MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO MISSION (US) 4.0/26; CORONARY DRUG-ELUTING STENT

Model Number	453960
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
An orsiro mission drug-eluting stent system was selected for treatment of the rca.A stent deformation was noticed before the device was inserted into the patients body.
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 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 stent is severely deformed at both ends.The stent has clearly been expanded on both ends.Besides of its expansion, the stent is deformed at its proximal end, several stent struts are everted.The balloon is still well folded but shows clear signs of inflation.Contrast medium residue was observed in the inflation lumen up to the distal balloon shoulder which implies that pressure has been applied to the stent system during preparation.Stent imprints are clearly visible on the exposed balloon surface, indicating that the deformed stent struts were initially crimped on the balloon.A reference stent protector could not be applied over the deformed struts without bending them further.It can therefore be excluded beyond reasonable doubt that the damage was already present on delivery of the instrument.Review of the product release documentation confirmed that the device was manufactured according to specifications and fulfilled all the requirements of in-process and final inspection.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 based on the conducted investigations of the device being subject to this complaint, no material or manufacturing related root cause could be determined.The root cause for the complaint event is most likely related to the handling during the preparations for the intervention, i.E., application of pressure prior to placement of the stent across the target lesion which is warned against in the ifu.

• Brand Name: ORSIRO MISSION (US) 4.0/26
• 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: 17953899
• Report Number: 1028232-2023-05277
• Device Sequence Number: 7623831
• Product Code: NIQ
• UDI-Device Identifier: 07640130456167
• UDI-Public: (01)07640130456167(17)2504
• Combination Product (Y/N): Y
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2023

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: 04/18/2025
• Device Model Number: 453960
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 03234094
• 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: Not provided
• Supplement Date Received by Manufacturer: 11/03/2023
• Initial Report FDA Received Date: 10/17/2023
• Supplement Report FDA Received Date: 11/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/20/2023
• 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: Male