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	H7493926008350
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Death (1802)
Date of Event	02/04/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
Device is a combination product.Device evaluated by mfr: the complaint device was not received for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is anticipated procedural complication as the event is due to a known physiological effect of the procedure noted within the directions for use, and/or device labeling.(b)(4).
Event or Problem Description
Same case as mdr id: 2134265-2018-05803.(b)(6) study.It was reported that the subject died.In (b)(6) 2018, the subject presented with stable angina (ccs classification: 2) and was referred for elective cardiac catheterization.Target lesion #1 was located in proximal left anterior descending artery (lad) with 80% stenosis and was 8 mm long with a reference vessel diameter of 3.5 mm.Target lesion #1 was treated with pre-dilatation and placement of a 3.50 x 8 mm study stent.Following, post-dilatation residual stenosis was 0%.Target lesion #2 was located in distal lad with 80% stenosis and was 20 mm long with a reference vessel diameter of 2.25 mm.Target lesion #2 was treated with pre-dilatation and placement of a 2.25 x 20 mm study stent with 0% residual stenosis.The subject was discharged on dual antiplatelet therapy.Sixteen days post index procedure, the subject was hospitalized due to acute on chronic congestive heart failure.The subject was discharged on dual antiplatelet therapy.Twenty-eight days post-index procedure, the subject was hospitalized in response to ¿foreign body removal: esophagus.¿ an interventional procedure was performed in response to the event.In (b)(6) 2018, the event was resolved with sequelae and the subject was discharged on dual antiplatelet therapy.One day later, the subject was admitted to hospice services with chief complaint of congestion and terminal diagnosis of chronic kidney disease stage 4, renal failure, congestive heart failure (chf) and chronic obstructive pulmonary disease (copd).The subject¿s lungs were noted to be diminished throughout and had some congestion in upper chest area with ejection fraction of 10%.Additionally, the subject was noted with multiple skin tear, ulcers and generalized edema.The dressings were applied to multiple skin tear.The subject¿s appetite was also poor and they were very weak, unable to walk anymore.The subject was provided with medications and oxygen continuously via nasal cannula.The subject was on do-not-resuscitate (dnr) comfort care per their wish.The subject expired in their home the next day.Per the death certificate, the immediate cause of death was ischemia cardiomyopathy with underlying conditions of coronary artery disease and hypertension.The other significant conditions contributing to death were acute on chronic renal insufficiency, hyperkalemia and esophageal dysmotility.An autopsy was not performed.

• 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: 7647822
• Report Number: 2134265-2018-05802
• Device Sequence Number: 16531617
• Product Code: NIQ
• UDI-Device Identifier: 08714729840008
• UDI-Public: 08714729840008
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/07/2018

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: 07/19/2018
• Device Model Number: H7493926008350
• Device Catalogue Number: 39260-0835
• Device Lot Number: 20925428
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2018
• Initial Report FDA Received Date: 06/28/2018
• 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: Death
• Patient Age: 86 YR