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 H7493926020350

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

Patient Problems Death (1802); Edema (1820); Hemorrhage/Bleeding (1888)

Event Date 06/20/2017

Event Type  Death  

Manufacturer Narrative

Device is a combination product.Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

(b)(6) clinical study.It was reported that the patient died.In (b)(6) 2017, the patient presented due to unstable angina (braunwald classification : iiia) and was referred for cardiac catheterization.Subsequently, the index procedure was performed.The target lesion was located in the distal right coronary artery (rca) with 80% stenosis and was 20 mm long with a reference vessel diameter of 3.5 mm.The target lesion was treated with pre-dilatation and placement of a 3.50 x 20 mm synergy ii stent with 0% residual stenosis.The following day, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2017, the patient was hospitalized for an event of spontaneous and overt gastrointestinal bleeding.Blood transfusions were performed and four days later, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2017, the patient was re-hospitalized due to bilateral lower extremity edema and was treated medically.Three days later, the patient was discharged on aspirin and clopidogrel.However after thirteen days, the patient died due to an unknown cause.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that the patient died due to chronic obstructive pulmonary disease.

• 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: 6738690
• MDR Text Key: 80856253
• Report Number: 2134265-2017-07611
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729840183
• UDI-Public: (01)08714729840183(17)20171115(10)0020002349
• 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,Followup
• Report Date: 07/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/15/2017
• Device Model Number: H7493926020350
• Device Catalogue Number: 39260-2035
• Device Lot Number: 0020002349
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2016
• 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): Death; Hospitalization
• Patient Age: 81 YR