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

Model Number 10623

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

Patient Problem High Blood Pressure/ Hypertension (1908)

Event Date 08/14/2023

Event Type  Injury  

Manufacturer Narrative

E1.Initial reporter facility name: (b)(6).

Event Description

Synergy china registry.It was reported that patient experienced hypertension.In (b)(6) 2020, the subject was referred for cardiac catheterization and the index procedure was performed.The target lesion was located in the middle left anterior descending artery (lad) extending up to distal lad with 99% stenosis and was 37 mm long, with a reference vessel diameter of 2.75 mm.The target lesion was treated with pre-dilatation and followed by the placement of 2.75 mm x 38 mm synergy stent system.Following post-dilatation, the residual stenosis was noted to be 0%.Two days later, the subject was discharged on aspirin and clopidogrel.In (b)(6) 2023, the subject was diagnosed with grade 3 hypertension and was hospitalized on the same day for further treatment.Medication was given to treat the event.Four days later, the subject was discharged from the hospital.The outcome of the event was 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: 18387134
• MDR Text Key: 331283420
• Report Number: 2124215-2023-70134
• 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: 12/22/2023

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
• Device Expiration Date: 07/01/2020
• Device Model Number: 10623
• Device Catalogue Number: 10623
• Device Lot Number: 0023174756
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2023
• Initial Date FDA Received: 12/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2019
• 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: 65 YR
• Patient Sex: Male