MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO 3.0/26; CORONARY DRUG-ELUTING STENT

Model Number 364508

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

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

Event Date 04/12/2023

Event Type  malfunction  

Manufacturer Narrative

Combination product: yes.

Event Description

The orsiro drug-eluting stent system could not pass the heavy calcified lesion in the severely tortuous rca, and the shaft broke into two parts.The device was retrieved from patients body.Another orsiro was used to complete the intervention.

Manufacturer Narrative

Combination product: yes.The returned product was subjected to a detailed technical analysis and the corresponding product release documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.The technical investigation revealed that the hypotube has fractured about 31.5 cm distal to the kink protector.Several small kinks were observed at the proximal fragment of the hypotube whereas a strong kink was found about 2 cm distal to the fracture site at the distal fragment of the hypotube.The cross-sections of the hypotube are no longer circular but compressed and the polymer coating is plastically deformed.The findings indicate that the hypotube most probably fractured as a result of significant bending outside of the patients body.Review of the product release documentation confirmed that the instrument was manufactured according to specifications and passed all in-process and final inspections.Based on the conducted investigations, no manufacturing or material related root cause could be determined.The root cause for the complaint event is most likely related to the handling during the procedure.It should be noted that the ifu advises the user to not force the passage if any resistance is felt, and to exercise care during device handling to reduce the possibility of accidental breakage, bending, and kinking of the stent system shaft.

• Brand Name: ORSIRO 3.0/26
• 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: 16897434
• MDR Text Key: 314854106
• Report Number: 1028232-2023-02313
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 07640130411739
• UDI-Public: (01)07640130411739(17)2410
• 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,Followup
• Report Date: 06/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 364508
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 09226049
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2022
• 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