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

Model Number	364487
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Combination product: yes.
Event or Problem Description
An orsiro drug-eluting stent system was selected for treatment of a complex lcx - proximal diagonal vessel.Despite pre-dilatation it was not possible to pass the orsiro through the severely calcified lesion.The stent delivery system was withdrawn twice.Upon withdrawal, on attempt to re-insert the device, it was noticed that the stent has been dislodged from the balloon.However, it was not possible to locate the dislodged stent inside or outside the patients body.The delivery system was discarded at the hospital and is therefore not available for investigation.
Additional Manufacturer Narrative
Combination product: yes.Neither the complaint instrument nor the angiographic material was returned for analysis.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 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.Please note that the ifu warns against re-insertion if the orsiro stent system was removed prior to expansion as the stent and/or the delivery system may have been damaged during the initial attempt to cross the lesion or during withdrawal.

• Brand Name: ORSIRO 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: 14278547
• Report Number: 1028232-2022-02274
• Device Sequence Number: 6322996
• Product Code: NIQ
• UDI-Device Identifier: 07640130439023
• UDI-Public: 7640130439023
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• PMA/510(K) Number: P170030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2022

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: 09/21/2023
• Device Model Number: 364487
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 08212642
• 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: 04/29/2022
• Supplement Date Received by Manufacturer: 05/18/2022
• Initial Report FDA Received Date: 05/04/2022
• Supplement Report FDA Received Date: 05/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2021
• 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: Unknown