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

Device Problem Activation Failure (3270)

Patient Problems Angina (1710); Restenosis (4576)

Event Date 04/25/2022

Event Type  Injury  

Event Description

Agent ide study it was reported that angina and restenosis occurred.On (b)(6) 2020, the first obtuse marginal branch (1st om) was treated with a 4.00 mm x 20 mm synergy drug eluting stent and cutting balloon.On (b)(6) 2022, the subject presented with stable angina and the index procedure was performed on the same day.Loading doses of 325 mg of aspirin and 300 mg of clopidogrel were given prior to the procedure.Angiography revealed 90% in-stent-restenosis of the 1st om and intravascular ultrasound revealed under expansion of the 4.00 mm x 20 mm synergy stent at the target lesion.The target lesion was 8 mm long with a reference vessel diameter of 3.5 mm.The target lesion was predilated with 3.0 mm x 12 mm balloon.Following pre-dilation, the lesion was successfully treated with a 3.50 mm x 12 mm agent dcb study device with timi flow of 3.The subject was discharged on aspirin and clopidogrel.

• Brand Name: SYNERGY XD
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19051443
• MDR Text Key: 339492335
• Report Number: 2124215-2024-20818
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• 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: 04/05/2024

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/18/2024
• Initial Date FDA Received: 04/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Race: White