MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY; CORONARY DRUG-ELUTING STENT

Model Number 9533

Device Problem Obstruction of Flow (2423)

Patient Problem Restenosis (4576)

Event Date 06/20/2022

Event Type  Injury  

Event Description

Agent ide.It was reported that in-stent restenosis occurred.In (b)(6) 2020, the proximal left anterior descending artery (lad) was noted to be 100% stenosed and was treated with 2.5 mm x 20 mm and 3.0 mm x 16 mm synergy drug eluting stents.In (b)(6) 2022, a drug eluting stent was implanted in the right posterior descending artery (rpda).In (b)(6) 2022, cardiac catheterization revealed 70% in-stent restenosis in the mid lad/1st diagonal and 95% stenosis in the rpda.The subject was randomized into the agent ide study and the index procedure was performed on the same day.Heparin or other antithrombotic medication were administered at the time of index procedure.The target lesion was located in the rpda and was 12 mm long with a reference vessel diameter of 3.00 mm.The target lesion was predilated with a 3.25 mm x 15 mm balloon.Following pre-dilation, the lesion was successfully treated with a 3.25 mm x 15 mm nc quantum apex balloon resulting in 40% residual stenosis and timi flow of 3.The subject was discharged on clopidogrel.

• Brand Name: SYNERGY
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15680714
• MDR Text Key: 302491873
• Report Number: 2124215-2022-42997
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9533
• Device Catalogue Number: 9533
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/14/2022
• Initial Date FDA Received: 10/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Race: White