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 H7493926016350

Device Problem Occlusion Within Device (1423)

Patient Problems Chest Pain (1776); Occlusion (1984)

Event Date 03/20/2018

Event Type  Injury  

Manufacturer Narrative

Device is a 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

(b)(6).It was reported that chest pain and coronary restenosis occurred.In (b)(6) 2017, clinical status assessment indicated that the patient's qualifying condition was unstable angina.Subsequently, the patient was referred for cardiac catheterization and index procedure was performed.The target lesion was located in the mid right coronary artery (rca) with 95% stenosis and was 10mm long with a reference vessel diameter of 3.5mm.The target lesion was treated with pre-dilatation and placement of a 3.50x16mm study stent.Following post-dilatation the residual stenosis was 9%.On the same day, the patient was discharged on dual antiplatelet therapy.In (b)(6) 2018, the patient presented for follow-up of coronary artery disease.The patient complained of exertional chest pain.The patient was treated with beta blockers and calcium channel blocker but was without much improvement.The patient was recommended for cardiac catheterization due to anginal symptoms despite medical therapy.The following day, the patient presented for cardiac catheterization and coronary angiography revealed 90% proximal to mid stenosis just before the stented segment consistent with edge restenosis.It was treated with balloon angioplasty and placement 3.5 x 28mm synergy drug eluting stent following which residual stenosis was less than 10% with timi 3 flow.On the same day, the event was considered resolved.

• 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: 7437677
• MDR Text Key: 105718470
• Report Number: 2134265-2018-03258
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729840121
• UDI-Public: 08714729840121
• 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: 03/26/2018

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: 08/26/2017
• Device Model Number: H7493926016350
• Device Catalogue Number: 39260-1635
• Device Lot Number: 0019675736
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/26/2018
• Initial Date FDA Received: 04/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2016
• 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