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 H7493926038300

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/08/2018

Event Type  malfunction  

Manufacturer Narrative

Device is a combination product.  (b)(4).Device evaluated by mfr.: the device was not returned for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is device not returned as the complaint did not include returned device review and lacked the objective evidence or descriptive conditions of the event required to determine what could have contributed to the event.  (b)(4).

Event Description

Same case as mdr# 2134265-2018-06593, 2134265-2018-06594, and 2134265-2018-06595.It was reported that stent damage occurred.The target lesion was located in the left anterior descending artery (lad) extending to the left circumflex artery (lcx).A 3.00 x 38mm synergy ii drug-eluting stent (des) was advanced but failed to cross the lesion and was removed from the patient.The physician noticed the patient becoming unstable.A non-bsc left ventricular assist device was placed and chest compressions started.The same 3.00 x 38mm synergy ii des was selected for re-use and the physician noted that the stent struts were flared.The physician pressed the stent struts back onto the balloon but when the device was advanced using a guidezilla¿ ii guide extension catheter, the stent came off the balloon in the guidezilla.Both were removed together.A guidezilla¿ ii guide extension catheter was advanced and three synergy ii des were placed, two stents in the lad and one in the lcx, to compete the procedure.Later that day the patient died.The physician did not consider the death related to any of the devices.

• 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: 7665061
• MDR Text Key: 113285069
• Report Number: 2134265-2018-05796
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729840411
• UDI-Public: 08714729840411
• 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: 06/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/15/2019
• Device Model Number: H7493926038300
• Device Catalogue Number: 39260-3830
• Device Lot Number: 0021913317
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2018
• 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 Age: 90 YR