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 H7493926016250

Device Problems Migration or Expulsion of Device (1395); Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/22/2018

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.(b)(4).  device evaluated by mfr.: the device was not returned for analysis.A review of the manufacturing documentation found that all devices shipped to this site conformed to the preventive measures / current controls as per the product specification.The investigation conclusion is caused by other device as another device/drug/subsequent procedure caused the complaint event.(b)(4).

Event Description

Same case as mdr id# 2134265-2018-07141 and 2134265-2018-07142.It was reported that stent damage and stent migration occurred.The 85% stenosed target lesion was located in the severely tortuous and moderately calcified ostial of the left internal mammary artery.A 2.50 x 16mm synergy ii drug-eluting stent (des) was implanted and there was ostial lesion distal so the physician tried to get the wire down because of slow flow.A non-bsc balloon catheter was advanced to post-dilate the lesion.However, after several attempts and putting multiple balloons down, the implanted stent could not be crossed with another stent.A non bsc guide extension catheter was then advanced but it got caught in the stent, deforming it and pushing the stent all the way distal.A second synergy stent was implanted inside the migrated stent and the guide extension catheter was removed.A non bsc micro-guide catheter was then introduced and a third stent implanted.The non bsc micro-guide catheter caught on the second and third stents, pushing and deforming them.The patient went to surgery and the procedure was completed.No further patient complications were reported.

• 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: 7714914
• MDR Text Key: 114864401
• Report Number: 2134265-2018-06575
• Device Sequence Number: 1
• Product Code: NIQ
• 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: 07/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H7493926016250
• Device Catalogue Number: 39260-1625
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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