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 H7493926024300

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

Patient Problem Obstruction/Occlusion (2422)

Event Date 11/29/2016

Event Type  Injury  

Manufacturer Narrative

Age at time of event: upper 50's.Device is a combination product.Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

Same case as mdr id# 2134265-2016-11682, 2134265-2016-11685, and 2134265-2016-11684.It was reported that blood flow obstruction post stent deployment occurred.The target lesion was located in the very calcified left anterior descending (lad) artery.Following pre-dilatation, four synergy ii drug-eluting stents sized 2.50 x 24, 3.00 x 24, 2.75 x 20, and 3.00 x 16 were implanted to treat the lesion.However, post stent deployment, blood flow to the distal lad and several proximal diagonal branches of the lad was shut off.Subsequently, the patient had to be defibrillated when blood flow was lost.The proximal vessel was opened, the patient's rhythm was restored and the procedure was completed.The patient was kept on angiomax drip to open the distal lad and a balloon pump was placed for 48 hours.No further patient complications were reported and the patient survived.

• 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: 6190328
• MDR Text Key: 62854991
• Report Number: 2134265-2016-11683
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729840237
• UDI-Public: (01)08714729840237(17)20170824(10)19660585
• 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: 11/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/24/2017
• Device Model Number: H7493926024300
• Device Catalogue Number: 39260-2430
• Device Lot Number: 19660585
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2016
• 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