MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM

Model Number 10605

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

Patient Problems Death (1802); Cardiogenic Shock (2262)

Event Date 08/28/2017

Event Type  Death  

Manufacturer Narrative

Device is a combination product.

Event Description

(b)(6) study.It was reported that cardiogenic shock and death occurred.In (b)(6) 2016, due to a clinical status assessment indicating the qualifying condition of unstable angina, the patient was referred for cardiac catheterization.The target lesion was 95% stenosed, 20 mm long with a reference vessel diameter of 2.5 mm located in the distal right coronary artery (rca).The target lesion was treated with pre dilatation and placement of a 2.75 x 28 mm study stent with 0% residual stenosis.The patient was discharged on dual antiplatelet therapy.In (b)(6) 2017, the patient was diagnosed with non-st segment elevation myocardial infarction considered not related to the device.As there were no acute wall motion abnormalities in the distribution of the previously placed bypass grafts, the physician deemed that no coronary angiography was required.Two days later, the ejection fraction was improved from 30% to 50% and wall motion abnormality was consistent with obstruction of the posterior circumflex artery per analysis.The patient had a change in medication dose of isosorbide mononitrate along with reduction of dose in amlodipine during the hospital course.The patient was discharged with dual anti-platelet medications.Twenty days later the patient was hospitalized due to cardiogenic shock.On the same day, the patient expired.The cause of death was cardiogenic shock.It was unknown whether an autopsy was performed or not.

• Brand Name: SYNERGY
• Type of Device: BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8417572
• MDR Text Key: 138699859
• Report Number: 2134265-2019-02362
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729840282
• UDI-Public: 08714729840282
• 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: 03/13/2019

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: 09/23/2016
• Device Model Number: 10605
• Device Catalogue Number: 10605
• Device Lot Number: 0018468288
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/20/2019
• Initial Date FDA Received: 03/13/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Death
• Patient Age: 64 YR