MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY SYNERGY¿; CORONARY DRUG-ELUTING STENT

Model Number H7493926220250

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

Patient Problems Congestive Heart Failure (1783); Death (1802); Cardiogenic Shock (2262); Respiratory Failure (2484)

Event Date 01/25/2017

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.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The cause of the reported difficulties could not be determined.(b)(4).

Event Description

(b)(4) clinical study.Same case as mfr report#: 2134265-2017-02334.It was reported that post a coronary artery drug eluting stenting treatment procedure, the patient expired.The subject was referred for cardiac catheterization and in december 2016, the index procedure was performed.Target lesion #1 was located in the proximal lad with 80% stenosis and was 15 mm long with a reference vessel diameter of 2.5 mm.Target lesion #1 was treated with direct placement of a 2.50 x 20 mm study stent and the residual stenosis was 0%.Target lesion #2 was located in the ramus with 70% stenosis and was 28 mm long with a reference vessel diameter of 2.25 mm.Target lesion #2 was treated with direct placement of a 2.25 x 32 mm study stent and the residual stenosis was 10%.The patient was discharged on dual antiplatelet therapy (aspirin and clopidogrel) 7 days later.In (b)(6) 2017, event of death was reported.The patient had acute respiratory failure that led to death.No additional information and source documents are available at this point of time.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that per death certificate acute respiratory failure, cardiogenic shock, congestive heart failure and diabetes mellitus were stated as the cause of death.

• Brand Name: SYNERGY¿
• Type of Device: CORONARY DRUG-ELUTING STENT
• 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: 6437322
• MDR Text Key: 70966888
• Report Number: 2134265-2017-02333
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: SIMILAR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/06/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 07/02/2017
• Device Model Number: H7493926220250
• Device Catalogue Number: 39262-2025
• Device Lot Number: 18788313
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/06/2017
• Initial Date FDA Received: 03/27/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2016
• 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
• Patient Age: 81 YR