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 Cardiomyopathy (1764); Death (1802); Myocardial Infarction (1969); Respiratory Failure (2484)

Event Date 08/19/2019

Event Type  Death  

Manufacturer Narrative

Device is a combination product.

Event Description

(b)(6) clinical study.It was reported that cardiac and respiratory arrest occurred and the patient died.In (b)(6) 2019, the subject was referred for cardiac catheterization and the index procedure was performed on the same day.The target lesion was located in the mid left anterior descending artery with 99% stenosis and was 34 mm long and a reference vessel diameter of 3.00 mm.The lesion was treated with pre-dilatation and placement of a 3.00 mm x 38 mm promus premier stent with 10% residual stenosis.Post-dilation was not performed.The subject was discharged six days later on aspirin and other antiplatelet medication.In (b)(6) 2019, the subject was diagnosed with "coronary heart disease (mixed) (ischemic cardiomyopathy + myocardial infarction)" and was subsequently hospitalized on the same day.Five days later, the event was considered to be recovering/resolving and the subject was discharged.At the time, this event was noted to be, not related to the study stent.Eleven days later (62 days post procedure) the subject died due to a cardiac and respiratory arrest.

Manufacturer Narrative

Date of death updated from (b)(6) 2019 to (b)(6) 2019.Date of event updated from (b)(6) 2019 to (b)(6) 2019.Describe event or problem: the patient died in (b)(6) 2019, 123 days post index procedure, not in (b)(6) 2019 as previously reported.Device is a combination product.

Event Description

Promus premier clinical study it was reported that cardiac and respiratory arrest occurred and the patient died.In (b)(6) 2019, the subject was referred for cardiac catheterization and the index procedure was performed on the same day.The target lesion was located in the mid left anterior descending artery with 99% stenosis and was 34 mm long and a reference vessel diameter of 3.00 mm.The lesion was treated with pre-dilatation and placement of a 3.00 mm x 38 mm promus premier stent with 10% residual stenosis.Post-dilation was not performed.The subject was discharged six days later on aspirin and other antiplatelet medication.In (b)(6) 2019, the subject was diagnosed with "coronary heart disease (mixed) (ischemic cardiomyopathy + myocardial infarction)" and was subsequently hospitalized on the same day.Five days later, the event was considered to be recovering/resolving and the subject was discharged.At the time, this event was noted to be, not related to the study stent.It was further reported that the patient died in (b)(6) 2019, 123 days post index procedure, not in (b)(6) 2019 as previously reported.

Manufacturer Narrative

Device is a combination product.

Event Description

Promus premier china registry.It was reported that cardiac and respiratory arrest occurred and the patient died.In (b)(6) 2019, the subject was referred for cardiac catheterization and the index procedure was performed on the same day.The target lesion was located in the mid left anterior descending artery with 99% stenosis and was 34 mm long and a reference vessel diameter of 3.00 mm.The lesion was treated with pre-dilatation and placement of a 3.00 mm x 38 mm promus premier stent with 10% residual stenosis.Post-dilation was not performed.The subject was discharged six days later on aspirin and other antiplatelet medication.In (b)(6) 2019, the subject was diagnosed with "coronary heart disease (mixed) (ischemic cardiomyopathy + myocardial infarction)" and was subsequently hospitalized on the same day.Five days later, the event was considered to be recovering/resolving and the subject was discharged.At the time, this event was noted to be, not related to the study stent.It was further reported that the patient died in (b)(6) 2019, 123 days post index procedure, not in (b)(6) 2019 as previously reported.On the same day, the subject was noted to be breathless and a heartbeat was not detected, subject died at home.The primary cause of death was cardiac and respiratory arrest and no action was taken to treat the event.An autopsy was not performed.

• 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: 8965066
• MDR Text Key: 156602020
• Report Number: 2134265-2019-10473
• 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: 03/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/04/2020
• Device Model Number: 9554
• Device Catalogue Number: 9554
• Device Lot Number: 0022350663
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 78 YR