MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO MISSION (US) 3.5/22; CORONARY DRUG-ELUTING STENT

Model Number	453953
Medical Device Problem Codes	Fluid/Blood Leak (1250); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
An orsiro mission drug-eluting stent system was selected for treatment of a lesion (stenosis degree: 95 percent) in the mildly tortuous mid svg to diagonal.A shockwave pre-dilatation was done over a filter-wire protection device.The orsiro mission was introduced but could not be inflated more than 2 atm due to hole in balloon.Stent and balloon had to be removed with guide catheter and sheath.
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 this event.In addition, the angiographic material provided was reviewed.The delivery system and the stent were returned inside the guiding catheter used in the intervention.The stent was located on the distal end of a filterwire protection system.The stent is severely deformed over its entire length.The balloon of the affected delivery system shows signs of an inflation attempt.The distal balloon shoulder is slightly unfolded.Microscopic inspection of the balloon showed no damage or irregularity.A strong kink was observed in the device shaft about 6 mm distal to the guide wire exit port.During functional testing water was seen to emerge from the guide wire exit port.Microscopic inspection revealed a damage of the inflation lumen at the kink close to the the guide wire exit port.In addition, the hypotube was found strongly kinked about 642 mm and 724 mm distal to the kink protector.Review of the production documentation confirmed that the device was manufactured according to specifications and passed all in-process and final inspections.In addition to visual inspections each device is tested for air tightness by means of a helium leak test.We can therefore confirm that the instrument was delivered in a leak-proof condition.Based on the conducted investigations of the device being subject to this complaint, no material or manufacturing related root cause could be determined.
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 this event.In addition, the angiographic material provided was reviewed.The delivery system and the stent were returned inside the guiding catheter used in the intervention.The stent was located on the distal end of a filterwire protection system.The stent is severely deformed over its entire length.The balloon of the affected delivery system shows signs of an inflation attempt.The distal balloon shoulder is slightly unfolded.Microscopic inspection of the balloon showed no damage or irregularity.A strong kink was observed in the device shaft about 6 mm distal to the guide wire exit port.During functional testing water was seen to emerge from the guide wire exit port.Microscopic inspection revealed a damage of the inflation lumen at the kink close to the guide wire exit port.In addition, the hypotube was found strongly kinked about 642 mm and 724 mm distal to the kink protector.Review of the production documentation confirmed that the device was manufactured according to specifications and passed all in-process and final inspections.In addition to visual inspections each device is tested for air tightness by means of a helium leak test.We can therefore confirm that the instrument was delivered in a leak-proof condition.Based on the conducted investigations of the device being subject to this complaint, no material or manufacturing related root cause could be determined.

• Brand Name: ORSIRO MISSION (US) 3.5/22
• 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: 19154468
• Report Number: 1028232-2024-02187
• Device Sequence Number: 7861923
• Product Code: NIQ
• UDI-Device Identifier: 07640130456099
• UDI-Public: (01)07640130456099(17)250
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/28/2024

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: 07/04/2025
• Device Model Number: 453953
• Device Catalogue Number: 453953
• Device Lot Number: 06232630
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2024
• Supplement Date Received by Manufacturer: 05/08/2024; 10/28/2024
• Initial Report FDA Received Date: 04/22/2024
• Supplement Report FDA Received Date: 05/09/2024; 10/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/06/2023
• 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: 84 YR
• Patient Sex: Male