MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO MISSION 2.75/18; CORONARY DRUG-ELUTING STENT

Model Number 419121

Device Problem Failure to Advance (2524)

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

Event Date 02/26/2024

Event Type  malfunction  

Event Description

An orsiro mission drug-eluting stent system was selected for treatment of a moderately calcified lesion (90 percent stenosis degree) in the mildly tortuous ostial diagonal.The lesion was pre-dilated with two balloons.Subsequent angiography revealed a recoiled fibrotic lesion which was again dilated with a nc balloon and a cutting balloon.Thereafter, the affected device was introduced but unable to cross the diagonal lesion despite multiple attempts.The vessel was treated with several balloons and by implantation of two stents.

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.In addition, the angiographic material and the cathlab report provided were reviewed.The technical investigation showed that the balloon is well folded and shows no signs of inflation.The stent shows no damage or irregularity.The crimped diameter of the stent complies with the specification.The angiographic material shows multiple pre-dilations, followed by the attempt to cross the lesion with the affected device.After the affected device has been withdrawn, the lesion is pre-dilated again.Eventually, two stents are successfully implanted.Review of the production documentation confirmed that the device was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.The most probable root cause for the reported event is related to the patients anatomy.

• Brand Name: ORSIRO MISSION 2.75/18
• 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: 18975819
• MDR Text Key: 338746151
• Report Number: 1028232-2024-01642
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 07640130441811
• UDI-Public: (01)07640130441811(17)2501
• 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: 419121
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 12220042
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/09/2023
• 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