MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PROMUS ELITE; STENT, CORONARY, DRUG-ELUTING

Model Number 10676

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ischemia (1942); Vascular Dissection (3160)

Event Date 12/23/2021

Event Type  Injury  

Event Description

It was reported that a dissection occurred.A percutaneous transluminal coronary angioplasty was performed on the 100% stenosed, 30 x 3.50mm, target lesion located in a moderately tortuous and non-calcified mid right coronary artery (rca).Following pre-dilation, 32 x 3.50 promus elite mr was deployed in the rca.Following stent deployment, a proximal edge dissection was noted.It was noted that the dissection was a type b dissection, and was flow limiting.Another drug eluting stent was deployed to cover the dissection and complete the procedure.No further patient complications were reported and the patient status was fully recovered.

Event Description

It was reported that a dissection occurred.A percutaneous transluminal coronary angioplasty was performed on a mid right coronary artery (rca).A 32 x 3.50 promus elite mr was deployed in the rca.Following stent deployment, a proximal edge dissection was noted.It was noted that the dissection was a type b dissection, and was flow limiting.Another drug eluting stent was deployed to cover the dissection and complete the procedure.No further patient complications were reported and the patient status was fully recovered.It was further reported that vascular access was obtained via the right radial artery.The 100% stenosed, 30 x 3.50mm, target lesion was located in the moderately tortuous and non-calcified rca.It was noted that the lesion was predilated and was post dilated.The dissection was noticed after the promus elite stent implantation.

• Brand Name: PROMUS ELITE
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13191651
• MDR Text Key: 283401781
• Report Number: 2134265-2021-16539
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/12/2022
• Device Model Number: 10676
• Device Catalogue Number: 10676
• Device Lot Number: 0026439107
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/28/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention