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

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

Patient Problems Bradycardia (1751); Ischemia (1942); Restenosis (4576)

Event Date 04/12/2023

Event Type  Injury  

Event Description

Agent ide study.On an unspecified date, 3.00mm x 38mm and 3.00mm x 28mm promus elite stents were implanted in the mid right coronary artery (rca).On (b)(6) 2023, pet stress test revealed moderate inferoapical and inferolateral ischemia.The subject was recommended for coronary angiography to access stent patency and detect scarring/ in-stent restenosis.On (b)(6) 2023, ecg revealed sinus bradycardia with 1st degree a-v block.On (b)(6) 2023, the subject presented to hospital for planned diagnostic coronary angiography and was noted to have chest pain and fatigue as ongoing symptoms.The subject was hospitalized on the same day and underwent diagnostic coronary angiography which revealed 50% in-stent restenosis at mid segment rca associated with ischemia and abnormal ecg.The subject was diagnosed with class 2 symptoms and moderate ischemia.On (b)(6) 2023, the 95% stenosed obtuse marginal was treated with a 2.50 x 20mm promus elite stent resulting in residual stenosis of less than 10% and timi flow of 3.The event was considered resolved and the subject was discharged.

• Brand Name: PROMUS ELITE
• Type of Device: CORONARY DRUG-ELUTING STENT
• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 17288056
• MDR Text Key: 318676944
• Report Number: 2124215-2023-34612
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/15/2023
• Initial Date FDA Received: 07/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Race: White