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

Model Number 9554

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

Patient Problems Death (1802); Vasoconstriction (2126)

Event Date 09/14/2019

Event Type  Death  

Manufacturer Narrative

Device is combination product.

Event Description

(b)(6) study.It was reported that the patient died.In (b)(6) 2019, the subject was referred for cardiac catheterization and index procedure was performed on the same day.At the time of procedure, subject received anti-thrombin medication.The target lesion #1 was located in the proximal left anterior descending artery with 100% stenosis and was 34 mm long and a reference vessel diameter of 4.00 mm.The lesion was treated with pre-dilatation and placement of a 4.00 mm x 38 mm promus premier drug-eluting stent.Following this intervention, post dilation was performed with 10% residual stenosis with timi flow 3.The patient was discharged on aspirin and clopidogrel.In (b)(6) 2019, 245 days post index procedure, the subject was noted with coronary spasm and the subject died due to coronary spasm.No further information available at time of reporting.

Manufacturer Narrative

Device is combination product.B2 date of death: corrected from (b)(6) 2019 to (b)(6) 2019.

Event Description

Promus premier china study.It was reported that the patient died.In (b)(6) 2019, the subject was referred for cardiac catheterization and index procedure was performed on the same day.At the time of procedure, subject received anti-thrombin medication.The target lesion #1 was located in the proximal left anterior descending artery with 100% stenosis and was 34 mm long and a reference vessel diameter of 4.00 mm.The lesion was treated with pre-dilatation and placement of a 4.00 mm x 38 mm promus premier drug-eluting stent.Following this intervention, post dilation was performed with 10% residual stenosis with timi flow 3.The patient was discharged on aspirin and clopidogrel.In (b)(6) 2019, 245 days post index procedure, the subject was noted with coronary spasm and the subject died due to coronary spasm.No further information available at time of reporting.It was further reported that in (b)(6) 2019, 245 days post index procedure, the patient was hospitalized for further evaluation and treatment.254 days post index procedure, the patient died due to coronary artery spasm.

• 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: 9764294
• MDR Text Key: 181175245
• Report Number: 2134265-2020-02214
• 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: 03/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/30/2020
• Device Model Number: 9554
• Device Catalogue Number: 9554
• Device Lot Number: 0021703892
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 56 YR