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

Model Number 10671

Device Problem Break (1069)

Patient Problems Myocardial Infarction (1969); Thrombosis/Thrombus (4440); Heart Failure/Congestive Heart Failure (4446)

Event Date 02/02/2024

Event Type  Injury  

Event Description

It was reported that stent thrombosis occurred requiring additional intervention.The 85% stenosed target lesion was located in the severely tortuous and severely calcified right coronary artery.A 12 x 3.00 promus elite premier drug-eluting stent was advanced for treatment.However, during the procedure, the shaft was fractured 5cm from the hub.Due to movement in the previously implanted stent, the patient was hospitalized in the uco while awaiting stabilization after the stent was removed due to a shaft fracture.In addition, the patient developed an acute myocardial infarction from angor, and an angiography revealed acute thrombosis in the artery.The patient received dual antiplatelet treatment (dapt), comprising asa and clopidogrel, while tirofiban was used to treat the thrombosis.Only the previously placed stent was left, which was going to be the second stent to be implanted.The procedure was completed with a different device, and currently, the patient has been discharged with heart failure.No further issues were reported.

Manufacturer Narrative

B5.Describe event or problem updated.

Event Description

It was reported that thrombosis occurred.The 85% stenosed target lesion was located in the severely tortuous and severely calcified right coronary artery.A 12 x 3.00 promus elite premier drug-eluting stent was advanced for treatment.However, during the procedure, the shaft was fractured 5cm from the hub.Due to movement in the previously implanted stent, the patient was hospitalized in the uco while awaiting stabilization after the stent was removed due to a shaft fracture.In addition, the patient developed an acute myocardial infarction from angor, and an angiography revealed acute thrombosis in the artery.The patient received dual antiplatelet treatment (dapt), comprising asa and clopidogrel, while tirofiban was used to treat the thrombosis.Only the previously placed stent was left, which was going to be the second stent to be implanted.The procedure was completed with a different device, and currently, the patient has been discharged with heart failure.No further issues were reported.It was further reported that patient experienced chest discomfort due to insufficient blood flow.

• Brand Name: PROMUS ELITE
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18769432
• MDR Text Key: 336128037
• Report Number: 2124215-2024-10807
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: AR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10671
• Device Catalogue Number: 10671
• Device Lot Number: 0030436093
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2022
• 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): Hospitalization; Required Intervention