MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO 2.25/15; CORONARY DRUG-ELUTING STENT

Model Number 364481

Device Problem Failure to Deflate (4060)

Patient Problem Myocardial Infarction (1969)

Event Date 10/31/2023

Event Type  Injury  

Manufacturer Narrative

Combination product: yes.

Event Description

The orsiro drug-eluting stent system was chosen for treatment of mildly calcified lesion (80 percent stenosis degree) in the mildly tortuous mid om1.After pre-dilatation the stent was delivered smoothly.During inflation the balloon was expanding very slowly and no air was identifiable.After deflation the balloon remained fully expanded.No flushing, inflator change, multiple attempts of negative pressure application resolved the issue.Finally, a 50 ccm syringe was attached and a constant negative pressure was applied with simultaneous manual traction.The balloon was slowly evacuated.It revealed fully inflated.Due to the prolonged vessel occlusion the signs and symptoms of stemi developed.The patient was managed medically without any further consequences.

Manufacturer Narrative

Combination product: yes.Neither the affected product nor the angiographic material was returned.Therefore, no technical investigation on the subject could be performed.The production documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.Review of the production documentation verified that the device was manufactured according to specifications and fulfilled all the requirements of in-process and final inspection.Based on the conducted investigations, no material or manufacturing related root cause could be determined.

• Brand Name: ORSIRO 2.25/15
• 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: 18243199
• MDR Text Key: 329427709
• Report Number: 1028232-2023-06064
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 07640130411463
• UDI-Public: (01)07640130411463(17)2405
• 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: 01/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 364481
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 05220096
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2022
• 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
• Patient Outcome(s): Required Intervention