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

Catalog Number H7493941838300

Device Problems Material Puncture/Hole (1504); Activation Problem (4042)

Patient Problems Chest Pain (1776); Laceration(s) (1946)

Event Date 03/01/2022

Event Type  malfunction  

Event Description

An (b)(6) year old female admitted for chest pain.Medical decision to perform a left heart cath which required intervention.The heart cath stent failed to deploy because it had a hole in the balloon.The stent was removed and a new stent was successfully deployed.Removal of the stent did cause a small dissection that requires continued observation in the hospital.Fda safety report id# (b)(4).

• Brand Name: SYNERGY XD
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 13677699
• MDR Text Key: 286847897
• Report Number: MW5107893
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 03/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2023
• Device Catalogue Number: H7493941838300
• Device Lot Number: 27548932
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/04/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 84 YR
• Patient Sex: Female
• Patient Weight: 80 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White