MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO 3.0/22; CORONARY DRUG-ELUTING STENT

Model Number 364502

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/12/2024

Event Type  malfunction  

Manufacturer Narrative

Combination product: yes.

Event Description

An orsiro drug-eluting stent system was selected for treatment.When preparing the device on the table, the stent dislodged from the balloon during the removal of the plastic protector.Device was not used.

Manufacturer Narrative

Combination product: yes.25-mar-2024 additional event information: after investigation and clarification, it was confirmed that the orsiro drug-eluting stent system was introduced into the patient and positioned in the target lesion.The balloon of the delivery system was inflated as intended.After deflating the balloon, the physician was unable to locate the stent in the target lesion.Eventually the stent was found on the table outside of the patient, still attached to the protector.The returned product was subjected to a 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.The technical investigation revealed that the balloon of the delivery system is not well folded anymore and has clearly been inflated.Stent imprints are visible between the x-ray markers, indicating that the stent was initially crimped centered on the balloon.The stent was retuned on the transportation wire inside of the protector and is slightly waved over its entire length but not pinched.Review of the production documentation confirmed that the device 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 by means of manufacturing process output monitoring.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 advises the user to visually check the stent crimping for uniformity, no protruding struts, and centering on the balloon and verify that the stent is positioned between the proximal and distal balloon markers and not to use if any defects are noted.

• Brand Name: ORSIRO 3.0/22
• Type of Device: 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: 18789931
• MDR Text Key: 336791316
• Report Number: 1028232-2024-01019
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 07640130411678
• UDI-Public: (01)07640130411678(17)2510
• Combination Product (y/n): Y
• Reporter Country Code: CH
• PMA/PMN Number: P170030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 364502
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 09230973
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/09/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1