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

Model Number UNK776

Device Problem Occlusion Within Device (1423)

Patient Problems Death (1802); Thrombosis (2100)

Event Date 03/07/2018

Event Type  Death  

Manufacturer Narrative

Device is combination product.Device evaluated by mfr: the complaint device was not received for analysis.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 Description

Same case as mdr# 2134265-2018-05835.(b)(6) study.It was reported that stent thrombosis and death occurred.In (b)(6) 2018, the patient presented with unstable angina (ccs classification: iib) and was referred for elective cardiac catheterization.Target lesion #1 was located in the mid right coronary artery (rca) with 80% stenosis and was 20 mm long with a reference vessel diameter of 3.5 mm.Target lesion #1 was treated with direct placement of 3.50 x 20 mm study stent.Following, post-dilatation residual stenosis was 0%.Target lesion #2 was located in proximal left anterior descending artery (lad) with 80% stenosis and was 16 mm long with a reference vessel diameter of 3.0 mm.Target lesion #2 was treated with direct placement of a 3.00 x 20 mm study stent.Following, post-dilatation residual stenosis was 0%.In (b)(6) 2018, the patient died.Primary cause of death was stent thrombosis and stroke.Since sudden death occurred, stent thrombosis was considered and assessed as possibly related to study device.A death certificate is not available and it is not known if an autopsy was performed.

• Brand Name: SYNERGY¿
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7663844
• MDR Text Key: 113195161
• Report Number: 2134265-2018-05834
• 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
• Report Date: 06/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK776
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/08/2018
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 86 YR