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

Model Number 9554

Device Problem Obstruction of Flow (2423)

Patient Problem Reocclusion (1985)

Event Date 08/26/2019

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.

Event Description

(b)(6) clinical study.It was reported that in-stent restenosis occurred.In (b)(6) 2019, the subject presented with an unstable angina and was referred for cardiac catheterization.Index procedure was performed on the same day.The target lesion was located in the proximal right coronary artery (rca) extending up to distal rca with 95% stenosis and was 45 mm long, with a reference vessel diameter of 3.5 mm.The target lesion was treated with pre-dilatation and placement of 3.50 x 38 mm study stent.Following post-dilatation, the residual stenosis was 0%.Three days after, the subject was discharged on aspirin and clopidogrel.In (b)(6) 2019, the subject was diagnosed with in-stent restenosis of right coronary artery and was hospitalized for further evaluation on the same day.The event was treated medically.Three days after, the event was considered resolved and the subject was discharged home on the same day.

Event Description

Promus premier china clinical study.It was reported that in-stent restenosis occurred.In (b)(6) 2019, the subject presented with an unstable angina and was referred for cardiac catheterization.Index procedure was performed on the same day.The target lesion was located in the proximal right coronary artery (rca) extending up to distal rca with 95% stenosis and was 45 mm long, with a reference vessel diameter of 3.5 mm.The target lesion was treated with pre-dilatation and placement of 3.50 x 38 mm study stent.Following post-dilatation, the residual stenosis was 0%.Three days after, the subject was discharged on aspirin and clopidogrel.In (b)(6) 2019, the subject was diagnosed with in-stent restenosis of right coronary artery and was hospitalized for further evaluation on the same day.The event was treated medically.Three days after, the event was considered resolved and the subject was discharged home on the same day.It further reported that the target lesion was 38mm and not 45 mm, and that in (b)(6) 2019, coronary angiography was performed which revealed 100% restenosis in the proximal right coronary artery (rca) extending up to distal rca.The restenosis was treated with precutaneos coronary intervention resulting in timi flow of 3.

Manufacturer Narrative

Device is a combination product.

• 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: 9348865
• MDR Text Key: 167216655
• Report Number: 2134265-2019-14168
• 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
• Report Date: 05/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9554
• Device Catalogue Number: 9554
• Device Lot Number: 0022855947
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 48 YR