MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO MISSION (US) 2.25/18; CORONARY DRUG-ELUTING STENT

Model Number	453943
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Combination product: yes neither the complaint instrument nor the angiographic material was returned.Therefore, no technical investigation on the subject could be performed.The product release documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.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.
Event or Problem Description
An orsiro mission drug-eluting stent system was selected for treatment.The physician intended to treat a mildly calcified lesion (100 percent stenosis degree, vessel reference diameter 2.5 mm, lesion length 18 mm) in a mildly tortuous part of the distal lcx.It is noted that there was an older stent more proximal to the lesion with a mild-moderate in-stent restenosis.After pre-dilation with a 2.0 x 12 mm balloon and subsequent thrombectomy, the complaint instrument was introduced and advanced towards the target lesion in the distal lcx but could not cross the previously implanted stent in the mid lcx.The complaint instrument was withdrawn.However, after withdrawal of the complaint instrument it was noticed that the stent had dislodged from the balloon.The dislodged stent was located in the proximal lcx where it was adapted to the vessel wall with a 3.5 x 12 mm nc balloon.

• Brand Name: ORSIRO MISSION (US) 2.25/18
• 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: 15690790
• Report Number: 1028232-2022-05549
• Device Sequence Number: 12462923
• Product Code: NIQ
• UDI-Device Identifier: 07640130455993
• UDI-Public: (01)07640130455993(17)2308
• 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: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/10/2022

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: 08/13/2023
• Device Model Number: 453943
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 06214845
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2022
• Initial Report FDA Received Date: 10/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/13/2021
• 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
• Patient Sex: Female