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

Model Number 10674

Device Problem Obstruction of Flow (2423)

Patient Problem Thrombosis (2100)

Event Date 07/10/2020

Event Type  Injury  

Event Description

It was reported that thrombosis occurred.Vascular access was obtained via the femoral artery.The 90% stenosed, de novo target lesion was located in the mildly tortuous and moderately calcified left anterior descending artery.Four promus elite stents were implanted, 2.50x24mm, 2.75x16mm, 3.00x24mm and 2.75x28mm.Post procedure the patient was on aspirin and dapt statin.The next day, it was noted that the 3.00x24mm and the 2.75x28mm promus elite drug-eluting stents were completely blocked.The procedure was completed with another of the same device.The patient was stable.It was further reported the next day the patient had chest pain and discomfort before it was noted the two stents were blocked.The blockage was treated with a balloon after which the patient was stable and responding well to medications.

Manufacturer Narrative

Device is a combination product.

Event Description

It was reported that thrombosis occurred.Vascular access was obtained via the femoral artery.The 90% stenosed, de novo target lesion was located in the mildly tortuous and moderately calcified left anterior descending artery.Four promus elite stents were implanted, 2.50x24mm, 2.75x16mm, 3.00x24mm and 2.75x28mm.Post procedure the patient was on aspirin and dapt statin.The next day, it was noted that the 3.00x24mm and the 2.75x28mm promus elite drug-eluting stents were completely blocked.The procedure was completed with another of the same device.The patient was stable.It was further reported the next day the patient had chest pain and discomfort before it was noted the two stents were blocked.The blockage was treated with a balloon after which the patient was stable and responding well to medications.It was later reported that stent thrombosis occurred.The patient was experiencing chest pain and discomfort.An angiogram was performed which led to the discovery of the thrombosis.Additional intervention was performed by advancing another balloon.After the intervention, the patient was on dual antiplatelet therapy (dapt).It was noted that antiplatelet medications, clopidogrel (300mg) and aspirin (300mg), were given before the procedure and at the time of patient discharge.Following the procedure, the patient was stable and responding well to medicines.

• Brand Name: PROMUS ELITE
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10444489
• MDR Text Key: 204086210
• Report Number: 2134265-2020-10618
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 09/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/26/2021
• Device Model Number: 10674
• Device Catalogue Number: 10674
• Device Lot Number: 0024855098
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR