MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO MISSION (US) 2.75/15; CORONARY DRUG-ELUTING STENT

Model Number	453939
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Combination product: yes.
Event or Problem Description
When attempting to treat a lesion in the cx atrioventricular groove, the stent advanced 2/3 through the lesion, then hypotube snapped in tuohy adapter.The guideliner was taken out, and the stent was tried to be withdrawn, but was withheld on an old stent.Everything was pulled out except the stent was floating in the cx.The stent was adapted to the vessel wall with a nc balloon.Never redelivered a new stent.
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 balloon is still well folded and shows no signs of inflation, however, dried contrast medium residue was observed in the inflation lumen up to the distal balloon shoulder, indicating the application of negative pressure.Stent imprints were observed on the exposed balloon surface, indicating that the stent was properly crimped in between the two radiopaque markers at the time of delivery.The hypotube has fractured about 15 cm distal to the distal end of the kink protector.Several kinks were observed along both sides of the fracture site.The cross-section of the hypotube at the fracture sites is no longer circular but compressed into an ellipse and the polymer coating is plastically deformed.The stent was not returned as reported.Review of the product release 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 of the device being subject to this complaint, no material or manufacturing related root cause was determined.The most probable root cause for the stent dislodgement is related to the handling during the procedure, i.E., application of negative pressure prior to the placement of the stent across the target lesion which is warned against in the ifu.The most probable root cause for the fracture of the hypotube is related to the handling during the procedure, i.E., excessive bending.The ifu advises the user to exercise care during device handling to reduce the possibility of disrupting the delicate placement of the stent on the balloon and accidental breakage, bending, kinking of the stent system shaft.

• Brand Name: ORSIRO MISSION (US) 2.75/15
• 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: 17214026
• Report Number: 1028232-2023-03201
• Device Sequence Number: 12315475
• Product Code: NIQ
• UDI-Device Identifier: 07640130455955
• UDI-Public: (01)07640130455955(17)2311
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: P170030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2023

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: 11/15/2023
• Device Model Number: 453939
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 10214628
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2023
• Supplement Date Received by Manufacturer: 08/10/2023
• Initial Report FDA Received Date: 06/27/2023
• Supplement Report FDA Received Date: 08/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/15/2021
• 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