MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO 2.5/15; CORONARY DRUG-ELUTING STENT SYSTEM

Model Number 364482

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 02/26/2024

Event Type  malfunction  

Event Description

An orsiro drug-eluting stent system was selected for treatment.During removal of the device from its plastic casing, the stent dislodged and remained on the wire inside the package.

Manufacturer Narrative

Combination product: yes.

Manufacturer Narrative

Combination product: yes.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 revealed that the balloon is still well folded but dried contrast medium residue was observed in the inflation lumen which is indicative for the application of negative pressure.Stent imprints on the exposed balloon surface further indicate that the stent was properly crimped in between the two radiopaque markers at the time of delivery.The stent was returned on the transportation wire just outside of the protector cap.The stent shows no damage or irregularity.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 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 could be determined.The most probable root cause for the reported event is related to the handling during the preparations for the intervention, i.E.Application of negative pressure prior to the placement of the stent across the target lesion which is warned against in the ifu.

• Brand Name: ORSIRO 2.5/15
• Type of Device: CORONARY DRUG-ELUTING STENT SYSTEM
• 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: 18939947
• MDR Text Key: 338336227
• Report Number: 1028232-2024-01532
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 07640130411470
• UDI-Public: (01)07640130411470(17)2511
• 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: 04/15/2024

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
• Device Operator: Health Professional
• Device Model Number: 364482
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 10234029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/15/2024
• Initial Date FDA Received: 03/20/2024
• Supplement Dates Manufacturer Received: 04/15/2024
• Supplement Dates FDA Received: 04/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/23/2023
• 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