MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO MISSION 3.5/18; CORONARY DRUG-ELUTING STENT

Model Number 419123

Device Problems Failure to Advance (2524); Material Deformation (2976)

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

Event Date 02/27/2024

Event Type  malfunction  

Event Description

An orsiro mission was selected for treatment.The affected device was visually checked prior to insertion into the three-step key/guiding catheter with no apparent anomaly.Afterwards, it was introduced without any resistance.However, halfway through the guiding catheter a resistance was noticed, and it was decided to remove the device.After the device was withdrawn, a deformation was noted.

Manufacturer Narrative

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 the reported event.The technical investigation showed that the stent is severely deformed at its distal end, i.E.Several struts are strongly bent.Stent imprints on the exposed balloon surface indicate that the bent struts were initially crimped on the balloon.Outside the deformed zone, the crimped diameter of the stent complies with the specification.Moreover, the device tip is deformed (i.E.Shows an indentation), and both the device shaft and the hypotube are mildly kinked.The guiding catheter used in the intervention was not returned.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.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 3.5/18
• 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: 18975817
• MDR Text Key: 338746149
• Report Number: 1028232-2024-01641
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 07640130441835
• UDI-Public: (01)07640130441835(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: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 419123
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 09236201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/02/2023
• 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