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	H7493926020220
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Codes	Angina (1710); Dyspnea (1816); Reocclusion (1985)
Date of Event	05/14/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Evolve short dapt clinical study.It was reported that in-stent restenosis occurred and the patient experienced angina.In april 2017, clinical status assessment indicated the patient's qualifying condition as stable angina and was referred for elective cardiac catheterization.Subsequently, index procedure was performed.The target lesion was located in the mid left anterior descending (lad) artery with 75% stenosis and was 18mm long with a reference vessel diameter of 2.25mm.The lesion was treated with pre-dilatation and placement of a 2.25x20mm synergy ii stent with 0% residual stenosis.The patient was discharged on aspirin and clopidogrel on the same day.In (b)(6) 2018, the patient experienced mid retro sternal chest pressure.The patient stated that she has had chest pain a couple of times in past few weeks that woke her up and were relieved with nitroglycerin.The patient also experienced shortness of breath.The patient was decided to proceed with cardiac catheterization for further evaluation.Four days after, the patient presented to the hospital for planned cardiac catheterization.On cardiovascular examinations, the patient was noted to have chest pain and paroxysmal nocturinal dyspnea.On the same day, cardiac catheterization revealed 75% in-stent restenosis of the study stent in the mid lad which was then was treated with pre-dilatation and placement of 2.50x15mm non-bsc stent with 0% residual stenosis.The event was considered to be resolved on the same day.

• Brand Name: SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
• Common Device Name: BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7626103
• Report Number: 2134265-2018-05552
• Device Sequence Number: 13798869
• Product Code: NIQ
• UDI-Device Identifier: 08714729840145
• UDI-Public: 08714729840145
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/30/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2017
• Device Model Number: H7493926020220
• Device Catalogue Number: 39260-2022
• Device Lot Number: 20051997
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2018
• Initial Report FDA Received Date: 06/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR