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

Model Number UNK776

Device Problem Occlusion Within Device (1423)

Patient Problems Atrial Fibrillation (1729); Cardiac Arrest (1762); Chest Pain (1776); Reocclusion (1985); Paralysis (1997); Thrombosis (2100); Ventricular Fibrillation (2130)

Event Date 02/14/2017

Event Type  Injury  

Manufacturer Narrative

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) study.It was reported that stent thrombosis occurred.In (b)(6) 2016, patient was referred for cardiac catheterization and index procedure was performed.Target lesion was located in the distal right coronary artery (rca) with 99% stenosis and was 38mm long with a reference vessel diameter of 2.75mm.The lesion was treated with pre-dilatation and placement of a 3.00x38mm synergy¿ study stent.Following post-dilatation residual stenosis was 0%.The following day, the patient was discharged on dual antiplatelet therapy (aspirin and clopidogrel).In (b)(6) 2017, the patient presented to emergency department with recurrent symptoms of chest pain.Shortly after admission patient had cardiac arrest with ventricular fibrillation.Patient was successfully resuscitated however, was noted to be paralyzed.Subsequently, patient was intubated and transferred to critical care unit.Electrocardiogram revealed atrial fibrillation with st depressions.Subsequently, coronary angiography was performed and revealed, 40% stenosis in mid rca, 95% in-stent restenosis (isr) of the previously placed study stent in distal rca; 70% stenosis in distal rca.On the same day, the 95% isr of previously placed study stent in distal rca and 70% stenosis in distal rca was treated with pre-dilatation and placement of a 3x22mm non-bsc drug-eluting stent.Following post dilatation the residual stenosis was 0%.The event was classified as stent thrombosis.During the course of hospitalization, patient was found to have upper gastro intestinal bleeding and esophagogastroduodenoscopy findings revealed varix in the esophagus and 2 arterio-venous malformations in the stomach.Computerised tomography of the chest revealed bilateral rib fractures, right pleural effusion with heterogeneous attenuation that could be hemorrhagic and pulmonary contusions.Nine days from the onset of symptoms, patient was discharged on aspirin.

Manufacturer Narrative

Describe event or problem updated.(b)(4).

Event Description

It was further reported that no stent thrombosis occurred in the previously implanted study stent in distal right coronary artery.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that in (b)(6) 2017, the patient presented to emergency department with sudden onset of chest pain and few days history of shortness of breath.The pain was sharp, midsternal and non-radiating in nature.The patient took one nitroglycerin at home following which improvement in pain was noted.On the same day, the patient was hospitalized for further investigation and treatment.Then, treatment with oral imdur was started.On the following day, event was considered resolved and the patient was discharged on aspirin and clopidogrel.

• 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: 6385595
• MDR Text Key: 69323098
• Report Number: 2134265-2017-01840
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: SIMILAR
• 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,Followup
• Report Date: 02/16/2017

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 Model Number: UNK776
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/16/2017
• Initial Date FDA Received: 03/07/2017
• Supplement Dates Manufacturer Received: Not provided; 03/19/2018
• Supplement Dates FDA Received: 04/14/2017; 04/11/2018
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 76 YR