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 H7493926012220

Device Problem Occlusion Within Device (1423)

Patient Problem Thrombosis (2100)

Event Date 01/29/2018

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.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# 2134265-2018-01210.It was reported that subacute stent thrombosis occurred.The target lesion was located at the bifurcation of the circumflex artery and the obtuse marginal branch (om).After a guide wire was advanced to the lesion, a 2.25 x 12mm synergy ii drug-eluting stent (des) was placed in the circumflex artery right at the bifurcation.The physician crossed the wire to the om and placed the second 2.25 x 12mm synergy ii des.A picture was taken with good results and the patient was sent home the following day.However, five days post procedure, the patient came back and was having a heart attack.The first picture, the stents looked some haziness then on the same day, they brought her back in and the second look, the stents were closed off, both of them.They had in-stent thrombosis.The doctor post dilated the stents with a couple of balloons and restored flow.The patient did fine.

• 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: 7290751
• MDR Text Key: 100756052
• Report Number: 2134265-2018-01209
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729840022
• UDI-Public: 08714729840022
• 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: 01/31/2018

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: 09/11/2018
• Device Model Number: H7493926012220
• Device Catalogue Number: 39260-1222
• Device Lot Number: 0021164696
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/31/2018
• Initial Date FDA Received: 02/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2017
• 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: 77 YR