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

Model Number 9549

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

Patient Problems Death (1802); Myocardial Infarction (1969); No Consequences Or Impact To Patient (2199); Heart Failure (2206)

Event Date 08/17/2019

Event Type  Death  

Manufacturer Narrative

Device is a combination product.

Event Description

(b)(6) clinical study.It was reported that myocardial infarction, heart failure occurred and patient died.In (b)(6) 2019, the subject presented with unstable angina and was referred for cardiac catheterization.Subsequently, index procedure was performed which revealed the target lesion #1 located in the left main coronary artery (lmca) to mid left anterior descending artery (lad) with 80% stenosis and was 10mm long, with a reference vessel diameter of 3.5 mm.The target lesion #1 was treated with pre-dilatation and placement of a 3.50 mm x 12 mm and 2.75mm x 16 mm promus premier stent.Following post dilation the residual stenosis was 0%.The target lesion #2 was located in the mid lad with 90% stenosis, and was 8 mm long with a reference vessel diameter of 3.50 mm.The target lesion #2 was treated with pre-dilatation and placement of a 2.75 x 16 mm study stent.Following post-dilatation, the residual stenosis was 0%.Ten days after, the subject was discharged on aspirin and clopidogrel.In (b)(6) 2019, 93 days post index procedure, the subject was diagnosed with myocardial infarction which led to the prolongation of existing hospitalization.It was noted the event led to the seriousness criteria of life threatening illness/injury but was not medically treated.Five days later, the subject passed away.Death certificate and autopsy reports are not available for the event at the moment.

Manufacturer Narrative

Correction: this device was reported in error.

Event Description

Promus premier china registry.It was reported that myocardial infarction, heart failure occurred and patient died.In (b)(6) 2019, the subject presented with unstable angina and was referred for cardiac catheterization.Subsequently, index procedure was performed which revealed the target lesion #1 located in the left main coronary artery (lmca) to mid left anterior descending artery (lad) with 80% stenosis and was 10mm long, with a reference vessel diameter of 3.5 mm.The target lesion #1 was treated with pre-dilatation and placement of a 3.50 mm x 12 mm and 2.75mm x 16 mm promus premier stents.Following post dilation the residual stenosis was 0%.The target lesion #2 was located in the mid lad with 90% stenosis, and was 8 mm long with a reference vessel diameter of 3.50 mm.The target lesion #2 was treated with pre-dilatation and placement of a 2.75 x 16 mm study stent.Following post-dilatation, the residual stenosis was 0%.Ten days after, the subject was discharged on aspirin and clopidogrel.In (b)(6) 2019, 93 days post index procedure, the subject was diagnosed with myocardial infarction which led to the prolongation of existing hospitalization.It was noted the event led to the seriousness criteria of life threatening illness/injury but was not medically treated.Five days later, the subject passed away.Death certificate and autopsy reports are not available for the event at the moment.It was previously reported that two stents were implanted in the lmca to mid-lad, but now it is reported the target lesion #1 was only located in the lmca and was 10mm long.The lesion was treated with only one stent, the 3.50x12mm promus premier stent.

• 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: 9163218
• MDR Text Key: 161490765
• Report Number: 2134265-2019-12113
• 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: 05/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9549
• Device Catalogue Number: 9549
• Device Lot Number: 0022911076
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 80 YR