MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORP., MARINA BAY CUST. FULFILLMENT CENTER BOSTON SCIENTIFIC SYNERGY; CORONARY DRUG-ELUTING STENT

Lot Number 28266143

Device Problem Material Frayed (1262)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/28/2022

Event Type  Injury  

Event Description

An 81-year-old male with past medical history guillain-barre, cad (coronary artery disease hyme present asthma, paroxysmal atrial fibrillation admitted with chest pain.Upon evaluation the patient was noted to be a nstemi.For cardiac catheterization with ciromay angiogram and possible stent placement.On (b)(6) 2022 cardiac catheterization was performed utilizing a 2.75 x 16 mm boston synergy xd.During withdrawal multiple strands of stent material came free and remain in the patient, possibly the aorta.Using micro ensnare several attempts were made to retrieve the fraying object but were unsuccessful.

• Brand Name: BOSTON SCIENTIFIC SYNERGY
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORP., MARINA BAY CUST. FULFILLMENT CENTER
• MDR Report Key: 15906168
• MDR Text Key: 304845535
• Report Number: MW5113583
• 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: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/10/2023
• Device Lot Number: 28266143
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 89 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White