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 Problems Anemia (1706); Fever (1858)

Event Date 04/27/2020

Event Type  Injury  

Event Description

Synergy china registry.It was reported that the patient experienced fever, hypokalemia, and anemia.In (b)(6) 2019, the subject presented with unstable angina and was referred for cardiac catheterization and on the same day index procedure was performed.The target lesion was located in the proximal left anterior descending artery (lad) extending up to distal lad with 80% stenosis and was 40 mm long, with a reference vessel diameter of 2.50 mm.The target lesion was treated with pre-dilatation and followed by the placement of a 2.50 mm x 32 mm and 2.75 mm x 16 mm synergy stent systems.Post procedure, the residual stenosis was noted to be 0%.Two days later, the subject was discharged on aspirin and ticagrelor.In (b)(6) 2020, the subject was diagnosed with hypopotassemia, mild anemia, and fever.All the events were treated with medication given or regimen adjusted.At the time of reporting, the hypopotassemia and mild anemia were considered not recovered/not resolved and the fever is considered to be recovering/resolving.

• 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: 17964478
• MDR Text Key: 326021376
• Report Number: 2124215-2023-56076
• 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: 10/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/27/2020
• Device Model Number: 10618
• Device Catalogue Number: 10618
• Device Lot Number: 0023055535
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2018
• 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
• Patient Age: 78 YR
• Patient Sex: Female