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

Model Number H7493926238350

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

Patient Problems Perforation of Vessels (2135); Cardiac Tamponade (2226)

Event Date 05/04/2018

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.(b)(4).

Event Description

Same case as mdr id: 2134265-2018-04654, 2134265-2018-04655, 2134265-2018-04646, 2134265-2018-04647, 2134265-2018-04659, 2134265-2018-04660.It was reported that vessel perforation and cardiac tamponade occurred.The patient presented with diffused calcification and narrowing of the left main (lm), left anterior descending (lad) and left circumflex (lcx); severe left ventricle (lv) dysfunction and aortic stenosis.This procedure was planned prior to an a transcatheter aortic valve implantation.Pre-dilation was completed with emerge¿ balloon catheters.Then three synergy¿ stents were implanted (4 x 24, 4 x 28 and a 3.5 x 38) were implanted.The stents were post dilated with nc emerge® balloon catheters.After post dilatation, a perforation was noted at the bifurcation of the lad and lcx.The perforation was treated by deploying non-bsc stents and further post dilatation of those stents.The perforation caused cardiac tamponade and pericardiocentesis was performed; a significant amount of blood was drained.The patient was stable prior to transfer to the intensive care unit.

• Brand Name: SYNERGY¿
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7506041
• MDR Text Key: 107961642
• Report Number: 2134265-2018-04656
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: SIMILAR
• 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: 05/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/25/2019
• Device Model Number: H7493926238350
• Device Catalogue Number: 39262-3835
• Device Lot Number: 21098180
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2017
• 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: 92 YR