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

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

Patient Problem Reocclusion (1985)

Event Date 11/09/2018

Event Type  Injury  

Manufacturer Narrative

Initial reporter facility name: (b)(6) hospital of (b)(6) medical university.

Event Description

(b)(6) clinical study.It was reported that post procedure stenosis occurred.In (b)(6) 2018, the subject was referred for cardiac catheterization and the index procedure was performed on the same day.Target lesion #1 was located in the distal left circumflex artery (lcx) with 99% stenosis and was 21mm long with a reference vessel diameter of 2.5mm.The lesion was pre-dilated, followed by treatment with 2.25x24mm promus premier drug-eluting stent.Following post dilatation, the residual stenosis was 0%.Target lesion #2 was located in the proximal lcx with 95% stenosis and was 35mm long with a reference vessel diameter of 3.0mm.The lesion was pre-dilated, followed by treatment with 3.00x38mm promus premier drug-eluting stent.Following post dilatation, the residual stenosis was 0%.Target lesion #3 was located in the left main coronary artery (lmca) with 99% stenosis and was 21mm long with a reference vessel diameter of 2.5mm.The target lesion was pre-dilated, followed by treatment with promus premier drug-eluting stent.However, post dilatation, percent diameter stenosis was still at 75%.No other information is available at this point of time.

Manufacturer Narrative

(e1)-initial reporter facility name: (b)(6).

Event Description

Promus premier china registry clinical study it was reported that post procedure stenosis occurred.In november 2018, the subject was referred for cardiac catheterization and the index procedure was performed on the same day.Target lesion #1 was located in the distal left circumflex artery (lcx) with 99% stenosis and was 21mm long with a reference vessel diameter of 2.5mm.The lesion was pre-dilated, followed by treatment with 2.25x24mm promus premier drug-eluting stent.Following post dilatation, the residual stenosis was 0%.Target lesion #2 was located in the proximal lcx with 95% stenosis and was 35mm long with a reference vessel diameter of 3.0mm.The lesion was pre-dilated, followed by treatment with 3.00x38mm promus premier drug-eluting stent.Following post dilatation, the residual stenosis was 0%.Target lesion #3 was located in the left main coronary artery(lmca) with 99% stenosis and was 21mm long with a reference vessel diameter of 2.5mm.The target lesion was pre-dilated, followed by treatment with promus premier drug-eluting stent.However, post dilatation, percent diameter stenosis was still at 75%.No other information is available at this point of time.It was further reported that post procedure stenosis at 75% was withdrawn.Inactivation of target lesion #3 was confirmed hence a downgraded complaint has been submitted for the same.No other information is available at this point of time.

• 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: 10832762
• MDR Text Key: 216015554
• Report Number: 2134265-2020-15799
• 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: 12/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/25/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 46 YR