MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO; CORONARY DRUG ELUDING STENT

Catalog Number SEE MODEL NO.

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 08/02/2022

Event Type  Injury  

Manufacturer Narrative

Combination product: yes.Only the product name (i.E.No size, no lot, no ref) and an event description were provided.The date of the initial procedure was not reported.The complaint instrument was not returned.Images of the case such as angiographies or ivus records could also not be obtained.Therefore, no complaint investigation could be performed.The additional information provided by the hospital (stent thrombosis case report) was not sufficient to establish whether a device deficiency could be the cause for this event.According to the stent thrombosis case report, only one antiplatelet drug was used but this was unrelated to the development of the very late stent thrombosis.Please note that, according to the ifu, administration of appropriate anticoagulant, antiplatelet and vasodilatation therapy is critical to successful stent implantation.

Event Description

In-stent restenosis in a patient who had orsiro placed 3 years ago.Pci was performed and evaluated by ivus, oct, and endoscopy.The stent was normally covered with the intima, but a thrombus adhered to the stent placement site, and it was judged to be a very late stent thrombosis (vlst).At the time of vlst, only one antiplatelet drug was used, but this is not considered to be the cause.The patients outcome is good and has already been discharged home.No lot number or size was available.

• Brand Name: ORSIRO
• Type of Device: CORONARY DRUG ELUDING 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: 15433349
• MDR Text Key: 300024387
• Report Number: 1028232-2022-04757
• Device Sequence Number: 1
• Product Code: NIQ
• 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,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization