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

Model Number 10603

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

Patient Problems Congestive Heart Failure (1783); Death (1802)

Event Date 08/27/2018

Event Type  Death  

Manufacturer Narrative

Device is a combination product.

Event Description

Evolve short dapt.It was reported a death had occurred.In (b)(6) 2018 the patient presented with unstable angina and was referred for elective cardiac catheterization.That same day, the procedure was performed.The target lesion was located in the mid left anterior descending artery with 85% stenosis and was 15 mm long with a reference vessel diameter of 3.0 mm.The lesion was treated with direct placement of 3.00 x 20 mm study stent with 0% residual stenosis and was discharged that same day on aspirin and clopidogrel.In (b)(6) 2018, the patient expired.Per the death certificate, coronary artery disease was the sequential condition leading to congestive heart failure.The manner of death was noted to be natural, and no autopsy was performed.

• 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: 7948692
• MDR Text Key: 123189074
• Report Number: 2134265-2018-61608
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729840176
• UDI-Public: 08714729840176
• 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: 10/09/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 05/04/2018
• Device Model Number: 10603
• Device Catalogue Number: 10603
• Device Lot Number: 0020624890
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/14/2018
• Initial Date FDA Received: 10/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2017
• 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: 77 YR