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	H7493926038220
Medical Device Problem Codes	Occlusion Within Device (1423); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Angina (1710); Atrial Fibrillation (1729); Congestive Heart Failure (1783); Dyspnea (1816); Fatigue (1849); Occlusion (1984); Reocclusion (1985); Chest Tightness/Pressure (2463)
Date of Event	08/22/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a combination product.The device was not returned for analysis.A review of the manufacturing documentation found that all devices shipped from the batch conformed to the preventive measures / current controls as per the product specification.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 or Problem Description
(b)(4) clinical study.It was reported that angina and coronary restenosis occurred.In (b)(6) 2016, clinical status assessment revealed the patient's qualifying condition as stable angina and the patient was referred for cardiac catheterization.Subsequently, the index procedure was performed.The target lesion was located in the proximal left circumflex (lcx) artery with 99% stenosis and was 12mm long with a reference vessel diameter of 2.25mm.The target lesion was treated with pre-dilatation and placement of 2.25x38mm synergy ii study stent.Following post-dilatation, the residual stenosis was 0%.On the same day, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2017, the site reported an event of class iii angina.Nine days later, the 89% stenosis in proximal lcx was treated with drug-eluting stent placement, post which residual stenosis was 0%.Subsequently, an interventional procedure was also performed in response to the event.On the same day, the event was considered resolved.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was further reported that the target lesion was a long lesion located in the proximal/mid lcx to the second obtuse marginal (om2).In (b)(6) 2017, chronic atrial fibrillation was noted.Nine days after, focal in-stent restenosis at the proximal edge in mid lcx stent was noted and treated.The non-bsc stent in the mid lcx jailed the ostium of om1 and a 2.75x12mm non-bsc stent was implanted in an overlapping manner.There was small stenosis at the distal edge of 3.5 x 28 mm non-bsc stent which was treated with balloon angioplasty with good angiographic result.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was further reported that in (b)(6) 2017, the patient came with the complaints of chest pressure and dyspnea on exertion, fatigue and class ii chronic heart failure (chf).The patient was referred for cardiac catheterization with possible percutaneous coronary intervention (pci) to assess ischemic induced chf and stent restenosis.Eight days later, 80-89% stenosis in mid left circumflex (lcx) was treated with pre-dilatation and placement of 2.75 x 12 mm non-bsc drug eluting stent.Following post dilatation, the residual stenosis was 0% with timi 3 flow.Post stent deployment in mid lcx, stenosis in om1 got worsened to 80% which was treated with pre-dilatation and placement of 3.5 x 28 mm non-bsc stent.Following post dilatation, the residual stenosis was 0% with timi 3 flow.Patient was sent home with discharge instructions.

• 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: 6899745
• Report Number: 2134265-2017-09504
• Device Sequence Number: 19034580
• Product Code: NIQ
• UDI-Device Identifier: 08714729840381
• UDI-Public: 08714729840381
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/07/2017

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: 07/07/2017
• Device Model Number: H7493926038220
• Device Catalogue Number: 39260-3822
• Device Lot Number: 19472110
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/07/2017
• Supplement Date Received by Manufacturer: 10/06/2017; 11/29/2017
• Initial Report FDA Received Date: 09/27/2017
• Supplement Report FDA Received Date: 10/25/2017; 12/20/2017
• 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: 67 YR