MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM

Model Number H7493926028300

Device Problem Occlusion Within Device (1423)

Patient Problems Chest Pain (1776); Thrombosis (2100); Ventricular Tachycardia (2132)

Event Date 08/16/2017

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.The complaint device was not received for analysis.A review of the manufacturing documentation found that all devices shipped from the batch conformed to the preventive measures / current controls as per the product specification.The root cause is anticipated procedural complications as this event is a known physiological effect of the procedure and is noted within the dfu.(b)(4).

Event Description

It was reported that chest pain and stent thrombosis occurred.The 90% stenosed target lesion was located in the proximal left anterior descending artery (lad).Following pre-dilation using a compliant balloon catheter, a 3.00 x 28mm synergy ii drug-eluting stent was implanted to the lesion.Angiography was performed and it was noted that in right anterior oblique (rao caud) view inside the distal end of the stent was not completely filled with contrast and had very small white discoloring.A 3.25x15 non-compliant balloon catheter was advanced for post-dilation.Angiograhy was again performed which revealed timi 3 flow.After the patient was sent to a holding area, they complained of chest pain.The patient was returned to the cath lab where it was noted that the proximal lad where the stent was implanted was completely blocked with thrombus.At some point, the patient went into ventricular tachycardia and electrical cardioversion was administered until normal sinus rhythm was established.A manual aspiration catheter was used to open up the vessel and restore blood flow.A 3.5 non-compliant balloon catheter was advanced to further post-dilate the stent and the procedure was completed.No further patient complications were reported and the patient¿s status was stable.

• Brand Name: SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
• Type of Device: BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
• 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: 6826367
• MDR Text Key: 83834368
• Report Number: 2134265-2017-08804
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729840299
• UDI-Public: (01)08714729840299(17)20171011(10)19861066
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/16/2017

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/11/2017
• Device Model Number: H7493926028300
• Device Catalogue Number: 39260-2830
• Device Lot Number: 19861066
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/16/2017
• Initial Date FDA Received: 08/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2016
• 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: 45 YR