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

Model Number 9553

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

Patient Problem Complaint, Ill-Defined (2331)

Event Date 06/03/2019

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.

Event Description

(b)(6) clinical study.It was reported that patient experienced coronary syndrome.In (b)(6) 2019, the subject was referred for cardiac catheterization.The target lesion #1 was located in the proximal circumflex (cx) artery extending into the distal cx with 90% stenosis and was 62 mm long, with a reference vessel diameter of 2.5 mm.The target lesion was treated with pre-dilatation and placement of 2.50 mm x 32 mm study stent.Following post dilation, residual stenosis was 0%.Three days later, the subject was discharged on aspirin and other antiplatelet medication.In (b)(6) 2019, 45 days post index procedure, the subject experienced coronary syndrome and was hospitalized for further evaluation on the same day.The event was not treated medically and the outcome is unknown.No further information is currently available but has been requested.

Event Description

Promus premier china registry clinical study.It was reported that patient experienced coronary syndrome.In (b)(6) 2019, the subject was referred for cardiac catheterization.The target lesion #1 was located in the proximal circumflex (cx) artery extending into the distal cx with 90% stenosis and was 62 mm long, with a reference vessel diameter of 2.5 mm.The target lesion was treated with pre-dilatation and placement of 2.50 mm x 32 mm study stent.Following post dilation, residual stenosis was 0%.Three days later, the subject was discharged on aspirin and other antiplatelet medication.In (b)(6) 2019, 45 days post index procedure, the subject experienced coronary syndrome and was hospitalized for further evaluation on the same day.The event was not treated medically and the outcome is unknown.No further information is currently available but has been requested.It was further reported that in (b)(6) 2019, the subject experienced acute coronary syndrome and was discharged on the same day of hospitalization.

Manufacturer Narrative

Device is a combination product.

Event Description

Promus premier china registry clinical study it was reported that patient experienced coronary syndrome.In (b)(6) 2019, the subject was referred for cardiac catheterization.The target lesion #1 was located in the proximal circumflex (cx) artery extending into the distal cx with 90% stenosis and was 62 mm long, with a reference vessel diameter of 2.5 mm.The target lesion was treated with pre-dilatation and placement of 2.50 mm x 32 mm study stent.Following post dilation, residual stenosis was 0%.Three days later, the subject was discharged on aspirin and other antiplatelet medication.In (b)(6) 2019, 45 days post index procedure, the subject experienced coronary syndrome and was hospitalized for further evaluation on the same day.The event was not treated medically and the outcome is unknown.No further information is currently available but has been requested.It was further reported that in (b)(6) 2019, the subject experienced acute coronary syndrome and was discharged on the same day of hospitalization.It was later reported that the event was treated medically and considered to be recovered.

• Brand Name: PROMUS PREMIER
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8860898
• MDR Text Key: 153268483
• Report Number: 2134265-2019-09206
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/02/2020

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
• Device Expiration Date: 07/13/2020
• Device Model Number: 9553
• Device Catalogue Number: 9553
• Device Lot Number: 0022401676
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/24/2019
• Initial Date FDA Received: 08/05/2019
• Supplement Dates Manufacturer Received: 08/06/2019; 08/17/2020
• Supplement Dates FDA Received: 08/28/2019; 09/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR