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

Model Number 9551

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

Patient Problem Reocclusion (1985)

Event Date 10/19/2018

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.

Event Description

Promus premier (b)(6) clinical study.It was reported that patient experience restenosis.In (b)(6) 2018, the patient was referred for cardiac catheterization and a promus premier drug eluting stent was implanted to treat an unspecified target lesion.Sixteen days later, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2018, the patient was noted with restenosis in the right original coronary artery and was hospitalized for further evaluation and treatment.The patient was treated with balloon dilatation.Nineteen days later, the patient was discharged and on the same day, the event was considered to be resolved.

Manufacturer Narrative

Device is a combination product.

Event Description

Promus premier china clinical study.It was reported that patient experience restenosis.In (b)(6) 2018, the patient was referred for cardiac catheterization and a promus premier drug eluting stent was implanted to treat an unspecified target lesion.Sixteen days later, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2018, the patient was noted with restenosis in the right original coronary artery and was hospitalized for further evaluation and treatment.The patient was treated with balloon dilatation.Nineteen days later, the patient was discharged and on the same day, the event was considered to be resolved.It was further reported that in (b)(6) 2018, the patient qualifying condition was myocardial infarction.They were referred for cardiac catheterization and index procedure was performed.The target lesion #1 was located in the proximal right coronary artery (rca) extending up to mid rca with 95% stenosis and was 20mm long, with a reference vessel diameter of 2.25mm.The target lesion #1 was treated with pre-dilatation and placement of a 2.25x24mm promus priemiere stent.Following this intervention, post dilatation was performed.The target lesion #2 was located in the distal rca with 95% stenosis and was 16mm long, with a reference vessel diameter of 2.25mm.The target lesion #2 was not treated with pre-dilatation and placement of a 2.25 mmx20mm promus priemiere stent.Following this intervention, post dilatation was performed.

Manufacturer Narrative

Device is a combination product.

Event Description

Promus premier china clinical study it was reported that patient experience restenosis.In (b)(6) 2018, the patient was referred for cardiac catheterization and a promus premier drug eluting stent was implanted to treat an unspecified target lesion.Sixteen days later, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2018, the patient was noted with restenosis in the right original coronary artery and was hospitalized for further evaluation and treatment.The patient was treated with balloon dilatation.Nineteen days later, the patient was discharged and on the same day, the event was considered to be resolved.It was further reported that in (b)(6) 2018, the patient qualifying condition was myocardial infarction.They were referred for cardiac catheterization and index procedure was performed.The target lesion #1 was located in the proximal right coronary artery (rca) extending up to mid rca with 95% stenosis and was 20mm long, with a reference vessel diameter of 2.25mm.The target lesion #1 was treated with pre-dilatation and placement of a 2.25x24mm promus priemiere stent.Following this intervention, post dilatation was performed.The target lesion #2 was located in the distal rca with 95% stenosis and was 16mm long, with a reference vessel diameter of 2.25mm.The target lesion #2 was not treated with pre-dilatation and placement of a 2.25 mmx20mm promus priemiere stent.Following this intervention, post dilatation was performed.It was further reported that the target lesion #2 was indeed treated with pre-dilation and placement of a 2.25 mmx20mm promus priemiere 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: 8171828
• MDR Text Key: 130615402
• Report Number: 2134265-2018-64429
• 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: 02/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/18/2019
• Device Model Number: 9551
• Device Catalogue Number: 9551
• Device Lot Number: 0021179954
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 68 YR