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

Model Number 10675

Device Problems Break (1069); Failure to Advance (2524)

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

Event Date 12/07/2022

Event Type  malfunction  

Event Description

It was reported that shaft break occurred.Vascular access was obtained ia the femoral artery.The 80% stenosed, 3.50 x 25mm, eccentric target lesion was located in the severely tortuous and moderately calcified right coronary artery which had a significant bend between 45 and 90 degrees.Following pre-dilation with 2.00 x 12, 2.50 x 15, and 2.75 x 12mm emerge balloons, a 3.50 x 28 promus elite dug eluting stent was advanced for treatment.Significant resistance was encountered while advancing and after many attempts to cross the lesion, the shaft broke while the device was outside the patient.A 3.50 x 22 non boston scientific stent was used to complete the procedure.There were no patient complications nor injuries reported.The patient was stable.

Event Description

It was reported that shaft break occurred.Vascular access was obtained via the femoral artery.The 80% stenosed, 3.50 x 25mm, eccentric target lesion was located in the severely tortuous and moderately calcified right coronary artery which had a significant bend between 45 and 90 degrees.Following pre-dilation with 2.00 x 12, 2.50 x 15, and 2.75 x 12mm emerge balloons, a 3.50 x 28 promus elite dug eluting stent was advanced for treatment.Significant resistance was encountered while advancing and after many attempts to cross the lesion, the shaft broke while the device was outside the patient.A 3.50 x 22 non boston scientific stent was used to complete the procedure.There were no patient complications nor injuries reported.The patient was stable.It was further reported that the shaft break at 28 cm from the hub.

Manufacturer Narrative

Updated b5.

• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16016924
• MDR Text Key: 307191461
• Report Number: 2124215-2022-53876
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: TS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/09/2022
• Device Model Number: 10675
• Device Catalogue Number: 10675
• Device Lot Number: 0026532091
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2020
• 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
• Treatment: INTERMEDIATE CHOICE GUIDEWIRE; INTERMEDIATE CHOICE GUIDEWIRE; MP 6 FR GUIDE CATHETER; MP 6 FR GUIDE CATHETER
• Patient Age: 65 YR
• Patient Sex: Male