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

Model Number 9543

Device Problems Obstruction of Flow (2423); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Angina (1710); Congestive Heart Failure (1783); Dyspnea (1816); Non specific EKG/ECG Changes (1817); Fatigue (1849)

Event Date 10/12/2018

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.

Event Description

(b)(6).It was reported that angina occurred.In (b)(6) 2013, clinical status assessment indicated that the patient's qualifying condition was stable angina.Prior to procedure, the patient was noted to have abnormal stress test, indicative of ischemia.Subsequently, coronary angiography and index procedure were performed.Target lesion #1 was located in the first obtuse marginal (om1) with 80% stenosis and was 20mm long with a reference vessel diameter of 2.5mm.The lesion was treated with pre-dilatation and placement of a 2.50x28mm study stent followed with 0% residual stenosis.Target lesion #2 was located in the om3 with 90% stenosis and was 20 mm long with a reference vessel diameter of 2.5 mm.The lesion was treated with pre-dilatation and placement of a 2.50x28mm study stent followed with 0% residual stenosis.On the same day, the patient was discharged on dual antiplatelet therapy.In (b)(6) 2018, the patient presented with the symptoms of angina, fatigue, dyspnea, class ii congestive heart failure (chf), chest discomfort and exertion relieved with rest.Given class iii angina, stent restenosis versus progression of coronary artery disease (cad) was suspected and ischemic evaluation was recommended.Electrocardiogram (ecg) revealed poor r wave progression-probable normal variant and low qrs voltage in precordial leads.Thirteen days later, 70-80% stenosis of the om1 was treated with the placement of a 2.25x18mm stent.Following post-dilatation and the residual stenosis was found to be 0% with timi 3 flow.On the same day, the patient was discharged on dual antiplatelet therapy.

Event Description

Clinical study evolve ll.It was reported that angina occurred.In (b)(6) 2013, clinical status assessment indicated that the patient's qualifying condition was stable angina.Prior to procedure, the patient was noted to have abnormal stress test, indicative of ischemia.Subsequently, coronary angiography and index procedure were performed.Target lesion #1 was located in the first obtuse marginal (om1) with 80% stenosis and was 20mm long with a reference vessel diameter of 2.5mm.The lesion was treated with pre-dilatation and placement of a 2.50x28mm study stent followed with 0% residual stenosis.Target lesion #2 was located in the om3 with 90% stenosis and was 20 mm long with a reference vessel diameter of 2.5 mm.The lesion was treated with pre-dilatation and placement of a 2.50x28mm study stent followed with 0% residual stenosis.On the same day, the patient was discharged on dual antiplatelet therapy.In (b)(6) 2018, the patient presented with the symptoms of angina, fatigue, dyspnea, class ii congestive heart failure (chf), chest discomfort and exertion relieved with rest.Given class iii angina, stent restenosis versus progression of coronary artery disease (cad) was suspected and ischemic evaluation was recommended.Electrocardiogram (ecg) revealed poor r wave progression-probable normal variant and low qrs voltage in precordial leads.Thirteen days later, 70-80% stenosis of the om1 was treated with the placement of a 2.25x18mm stent.Following post-dilatation and the residual stenosis was found to be 0% with timi 3 flow.On the same day, the patient was discharged on dual antiplatelet therapy.It was further reported that in-stent restenosis was noted through core-lab angiography.

Manufacturer Narrative

Device is a combination product.

• Brand Name: SYNERGY
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8121895
• MDR Text Key: 129020950
• Report Number: 2134265-2018-63274
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2013
• Device Model Number: 9543
• Device Catalogue Number: 9543
• Device Lot Number: 15687353
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 77 YR