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

Model Number 10632

Device Problem Activation Failure (3270)

Patient Problem Perforation of Vessels (2135)

Event Date 01/01/2019

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.Used (b)(6) 2019 as event date since the correct date was not available.

Event Description

It was reported that the stent insufficient apposition and vessel perforation occurred.The target lesion was located in the non calcified and non tortuous right coronary artery.A 4.00 x 48 synergy drug-eluting stent was placed but the stent was not able to expand properly.The physician used a nc balloon catheter to expand the stent but the vessel perforated.The physician deployed another stent to cover the vessel perforation and completed the procedure.No further complications were reported and the patient's status was stable but needed intensive care.

• Brand Name: SYNERGY
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8316681
• MDR Text Key: 135409547
• Report Number: 2134265-2019-00818
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/10/2019
• Device Model Number: 10632
• Device Catalogue Number: 10632
• Device Lot Number: 0022130158
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2018
• 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): Other; Required Intervention