MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO MISSION (US) 4.0/40; CORONARY DRUG-ELUTING STENT

Model Number	453978
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Combination product: yes.
Event or Problem Description
An orsiro mission drug-eluting stent system was selected for treatment.However, the orsiro mission stent separated from the balloon platform.When exiting the tip of the fortress with the catheter, the stent itself went (on its own without the catheter) down the sfa and lodged in the popliteal artery.An attempt was made to re-enter the stent with a balloon and to pull back the stent into the sheath.The stent was retrieved back up the sfa, but the balloon lost its hold.The stent dislodged again.Finally, the stent was removed with a snare.The scrub admitted that she pulled at the protective sleeve instead of the black tip of the stylet.This might have caused the stent to dislodge from the balloon platform.
Additional Manufacturer Narrative
Combination product: yes the returned product was subjected to a 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 of the delivery system has been inflated and was returned in a partially deflated state.Stent imprints are visible between the x-ray markers, indicating that the stent was initially crimped on the balloon.The stent was returned separately unprotected and is severely deformed (elongated) over its entire length.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.It should be noted that the ifu clearly states that the orsiro mission is indicated for improving coronary luminal diameter in patients, including those with diabetes mellitus, with symptomatic heart disease, stable angina, unstable angina, non-st elevation myocardial infarction or documented silent ischemia due to atherosclerotic lesions in the native coronary arteries with a reference vessel diameter of 2.25 mm to 4.0 mm and a lesion length of ? 36 mm.

• Brand Name: ORSIRO MISSION (US) 4.0/40
• 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: 17039423
• Report Number: 1028232-2023-02738
• Device Sequence Number: 17885915
• Product Code: NIQ
• UDI-Device Identifier: 07640130456341
• UDI-Public: (01)07640130456341(17)2503
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2023

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: 03/15/2025
• Device Model Number: 453978
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 02233314
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2023
• Supplement Date Received by Manufacturer: 07/05/2023
• Initial Report FDA Received Date: 06/01/2023
• Supplement Report FDA Received Date: 07/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2023
• 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 Age: 70 YR
• Patient Sex: Female