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 05/21/2019

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) 2018, the patient presented with unstable angina and was referred for cardiac catheterization.The target lesion was located in the left main coronary artery (lmca) to proximal left anterior descending artery (lad) with 86% stenosis and was 34mm long, with a reference vessel diameter of 3.0mm.The target lesion was treated with pre-dilatation and placement of 3.0x38mm study stent.Following post dilation, residual stenosis was 0%.Five days later, the patient was discharged on acetylsalicylic acid and clopidogrel.In (b)(6) 2019, the patient was noted with in-stent restenosis and was hospitalized.The 50% restenosis noted in the lmca extending to the proximal lad was treated with percutaneous coronary intervention.The event was considered recovered/resolved on the same day and the patient was discharged seven days later.

Manufacturer Narrative

Device is a combination product.B3: date of event corrected from (b)(6)2019 to(b)(6)2019.B5: describe event or problem - patient discharge was corrected to late to nine days later from the previously reported seven days.

Event Description

Promus premier china clinical study it was reported that in-stent restenosis occurred.In (b)(6)2018 , the patient presented with unstable angina and was referred for cardiac catheterization.The target lesion was located in the left main coronary artery (lmca) to proximal left anterior descending artery (lad) with 86% stenosis and was 34mm long, with a reference vessel diameter of 3.0mm.The target lesion was treated with pre-dilatation and placement of 3.0x38mm study stent.Following post dilation, residual stenosis was 0%.Five days later, the patient was discharged on acetylsalicylic acid and clopidogrel.In (b)(6)2019 , the patient was noted with in-stent restenosis and was hospitalized.The 50% restenosis noted in the lmca extending to the proximal lad was treated with percutaneous coronary intervention.The event was considered recovered/resolved on the same day and the patient was discharged seven days later.It was further reported that, nine days later from hospitalization, the event was considered recovered/resolved and on the same day the patient was discharged.

• 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: 8664700
• MDR Text Key: 146907388
• Report Number: 2134265-2019-06142
• 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: 02/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/20/2019
• Device Model Number: 9554
• Device Catalogue Number: 9554
• Device Lot Number: 0021425905
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR