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

Model Number 10618

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

Patient Problem Arteriosclerosis/ Atherosclerosis (4437)

Event Date 10/10/2020

Event Type  Injury  

Event Description

Synergy china registry.It was reported that the patient experienced coronary atherosclerotic cardiopathy.In (b)(6) 2019, the subject presented with unstable angina and was referred for cardiac catheterization.The target lesion #1 was located in the proximal right coronary artery (rca) extending up to middle rca with 95 % stenosis and was 35 mm long with a reference vessel diameter of 3.0 mm.Target lesion #1 was treated with pre-dilatation and placement of a 3.00 mm x 24 mm synergy stent overlapped with another 3.00 mm x 16 mm synergy stent system.Following post-dilation, the residual stenosis was noted to be 0%.Two days later, the subject was discharged on aspirin.In october 2020, the subject was diagnosed with coronary atherosclerotic cardiopathy and was hospitalized on the same day for further evaluation and treatment.Medication was given to treat the event.Two days later, the subject was discharged on aspirin.In january 2021, the event was considered recovered/resolved.

Manufacturer Narrative

E.Initial reporter city - (b)(6).E.Initial reporter phone: (b)(6).

• Brand Name: SYNERGY
• 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: 18181398
• MDR Text Key: 328630098
• Report Number: 2124215-2023-62518
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/26/2020
• Device Model Number: 10618
• Device Catalogue Number: 10618
• Device Lot Number: 0023280076
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2019
• 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): Required Intervention; Hospitalization
• Patient Age: 78 YR
• Patient Sex: Male