MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO 3.0/30; CORONARY DRUG-ELUTING STENT

Model Number 364514

Device Problems Fracture (1260); Failure to Advance (2524)

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

Event Date 01/21/2024

Event Type  malfunction  

Event Description

An orsiro drug eluting stent system was selected for treatment of a moderately calcified lesion in the moderately tortuous mid lad.The orsiro could not pass and the stent fractured.

Manufacturer Narrative

Combination product: yes.

Manufacturer Narrative

Combination product: yes.07-may-2024 additional information: after additional correspondence with the local staff, it was clarified that there was no fracture, and that the stent could not pass due to the heavy calcification.The affected device was withdrawn, and another stent was successfully implanted.Final angiogram showed a good result without residual stenosis and timi 3 flow.The returned product was subjected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.In addition, the cathlab report provided was reviewed.The technical investigation revealed that the stent is slightly opened at both ends and severely deformed at its proximal 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 of the deformed zone the crimped diameter of the stent still complies with the specification.The balloon is well folded but dried contrast medium residue was observed in the balloon- and inflation lumen which is indicative for the application of (negative) pressure.Review of the production documentation confirmed that the device 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.Based on the conducted investigations of the device being subject to this complaint, no material or manufacturing related root cause could be determined.Considering the additional information provided, the most probable root cause for the reported event is related to the patients anatomy (i.E.Calcified lesion).

• Brand Name: ORSIRO 3.0/30
• 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: 19059907
• MDR Text Key: 340113693
• Report Number: 1028232-2024-01923
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 07640130411791
• UDI-Public: (01)07640130411791(17)2406
• 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,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 364514
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 06221889
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/08/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/28/2022
• 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