MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO 2.5/35; CORONARY DRUG-ELUTING STENT

Model Number 391235

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

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

Event Date 03/04/2024

Event Type  malfunction  

Event Description

An orsiro drug-eluting stent system was selected for treatment of a moderately calcified lesion (stenosis degree: 90-95 percent) in the moderately tortuous lesion.Then stent was attempted to cross into the lcx to om, but despite pre-dilatation the lesion could not be crossed with the device.Furthermore, the stent was damaged.Another orsiro stent was used.

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.In addition, the angiographic material and the cathlab report provided were reviewed.The technical investigation showed that the balloon is still well folded and shows no signs of inflation, however, dried contrast medium residue was observed in the inflation lumen and in the balloon indicating the application of negative pressure prior to reaching the target lesion.The hypotube is slightly kinked 110 mm distal to the kink protector and at the guide wire exit port.The stent shows no damage or irregularity.The crimped diameter of the stent complies with the specification.The angiographic material shows multiple pre-dilations of the target lesion.The actual complaint event is not visible.The angiographic material does therefore not provide further relevant information regarding the root cause of the complaint.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.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 2.5/35
• 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: 18960628
• MDR Text Key: 338756710
• Report Number: 1028232-2024-01602
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 07640130436848
• UDI-Public: (01)07640130436848(17)2508
• 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: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 391235
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 08230151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2024
• Date Device Manufactured: 08/29/2023
• 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