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)

Event Date 03/31/2018

Event Type  Injury  

Manufacturer Narrative

Device is combination product.Device evaluated by mfr.: 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 id: 2134265-2018-03555.It was reported that chest pain and acute stent thrombosis occurred.In (b)(6) 2018, the patient presented with st-elevation myocardial infarction.Vascular access was obtained via the right femoral artery utilizing retrograde approach.The 100% stenosed, 12 mm in length target lesion was located in the proximal left anterior descending (lad) artery.A 6fr sheath was inserted and a guide wire was advanced and crossed the lesion.Following predilatation with a non-bsc balloon, a 3.00 x 28 mm synergy ii drug-eluting stent was deployed at 12 atmospheres (atm) for 16 seconds.A 3.25 x 15 mm nc emerge balloon catheter was advanced for further dilatation at 12 atm for 17 seconds.Following dilatation, the devices were removed and hemostasis was successfully obtained.Post procedure, the patient was given effient and was resting comfortably with no acute distress noted.Following completion of the percutaneous coronary intervention (pci), the patient was transferred to the intensive care unit (icu) where they complained of chest pain.Repeat electrocardiogram (ecg) was performed which showed the exact same pattern as prior to the pci and a repeat angiogram confirmed acute stent thrombosis at the proximal segment of the stent.A 3.5 mm x 15 mm nc emerge balloon catheter was advanced and inflated the entire stent at 10 atm for 11 seconds, 12 atm for 6 seconds, 12 atm for 8 seconds, and 12 atm for 12 seconds.The stent appeared to have a good apposition and the vessel re-opened with timi-3 flow but there was haziness at the proximal stent segment.The physician deployed a 3.5 x 18 mm non-bsc stent at 14 atm for 14 seconds to cover the proximal segment of the synergy stent.The initial 100% stenosis was reduced resulting in 0% residual with normal timi-3 flow.No further patient complications were reported and the patient's status was good.The patient was kept on aggrastat infusion for 18 hours and was discharged on dual-antiplatelet with aspirin and effient.The patient was enrolled in cardiac rehab upon discharge.

• 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: 7459087
• MDR Text Key: 106459712
• Report Number: 2134265-2018-03410
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729840299
• UDI-Public: 08714729840299
• 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: 04/02/2018

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: 01/02/2019
• Device Model Number: H7493926028300
• Device Catalogue Number: 39260-2830
• Device Lot Number: 21571288
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/02/2018
• Initial Date FDA Received: 04/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/02/2018
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Age: 62 YR