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 H7493926012250

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

Patient Problems Angina (1710); Dyspnea (1816); Edema (1820); Fatigue (1849)

Event Date 03/28/2017

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.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 root cause is anticipated procedural complications as this event is a known physiological effect of the procedure and is noted within the dfu.(b)(4).

Event Description

Same case as mdr id 2134265-2017-04803.(b)(4) clinical study.It was reported that angina occurred.In (b)(6) 2016, clinical status assessment indicated that the patient 's qualifying condition as stable angina and the index procedure was performed.Target lesion #1 was an isr of a previously placed taxus stent and an unknown stent located in the 1st diagonal branch with 80% stenosis and was 6mm long with a reference vessel diameter of 2.5mm.Target lesion #1 was treated with direct placement of a 2.50 x 12 mm synergy study stent and residual stenosis was 0%.Target lesion #2 was located in the distal left anterior descending (lad) artery with 80% stenosis and was 6mm long with a reference vessel diameter of 2.25mm.Target lesion #2 was treated with direct placement of a 2.25 x 12mm synergy study stent and residual stenosis was 0%.On the same day, the patient was discharged on dual antiplatelet therapy (aspirin and clopidogrel).In (b)(6) 2017, patient was seen by the physician with complaints of chest pain with exertion.The patient also had ankle edema and fatigue.The patient was referred for further ischemic evaluation and positron emission tomography (pet) nuclear stress test was scheduled.The patient was advised to continue aspirin, plavix and beta blockers.Six days later, the patient had telephoned in and reported having recurrent chest pressure on exertion with dyspnea consistent with previous angina.The scheduled pet nuclear stress test was cancelled and the patient was referred for cardiac catheterization for further evaluation.Norvasc was added to the patient's regimen.Three days later, electrocardiogram (ecg) was performed which revealed av paced rhythm, left axis deviation, left bundle branch block, possible inferior and later infract.Six days later, coronary angiography was performed and the patient was referred for re-stent percutaneous transluminal coronary angiography to 1st diagonal artery via sv graft.Eight days later, the 90% isr in the 1st diagonal artery was treated with pre-dilatation and placement of a 2.5 x 8mm synergy stent.Following post-dilatation, residual stenosis was mild and distal flow was timi-3.The patient was advised to continue aspirin, plavix, beta blockers and nitrates, and was discharged on the same day.

• 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: 6557481
• MDR Text Key: 74838543
• Report Number: 2134265-2017-04802
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729840039
• UDI-Public: (01)08714729840039(17)20170203(10)0018940781
• 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: 04/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/03/2017
• Device Model Number: H7493926012250
• Device Catalogue Number: 39260-1225
• Device Lot Number: 0018940781
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR