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

Model Number UNK776

Device Problems Occlusion Within Device (1423); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Anemia (1706); Chest Pain (1776); Congestive Heart Failure (1783); Dyspnea (1816); Cardiac Enzyme Elevation (1838); Myocardial Infarction (1969); Occlusion (1984); Thrombosis (2100)

Event Date 01/23/2017

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.Device evaluated by mfr: the complaint device was not returned for analysis.The batch number is unknown and the manufacturing records for the complaint device could not be reviewed.The root cause is anticipated procedural complications as this event is a known physiological effect of the procedure and is noted within the dfu.(b)(4).

Event Description

Same case as mdr id: 2134265-2017-01955 and 2134265-2017-01956.Same patient as mdr id: 2134265-2017-00425 and 2134265-2017-00426.(b)(6).It was reported that myocardial infarction(mi), congestive heart failure, and restenosis occurred.In (b)(6) 2016, clinical status assessment indicated that the patient's qualifying condition was unstable angina.The patient was referred for cardiac catheterization.On the same day, index procedure was performed.Target lesion #1 was located in the proximal left circumflex(lcx) with 80% stenosis and was 12mm long with a reference vessel diameter of 2.75mm.Target lesion #1 was treated with direct placement of a 2.75x16mm synergy¿ drug-eluting study stent and the residual stenosis was 0%.The following day, the patient was discharged on dual antiplatelet therapy.In (b)(6) 2017, the patient had continued intermittent angina and was brought back for lad(left anterior descending) intervention.The entire length of previously placed stents (unknown manufacturer) in proximal and mid was treated with pre-dilatation and placement of two 2.75x38mm and one 2.25x38mm synergy¿ drug-eluting stents in an overlapping manner.Following post dilatation of all three stents, timi 3 flow was noted.Four days after, the patient was discharged on acetyl salicylic acid.Fourteen days after, the patient presented to emergency department with the complaints of acute left sided chest pain with minimal shortness of breath.The patient stated that this was similar to the prior chest pain.The patient was diagnosed with acute on chronic congestive heart failure(chf), st elevation myocardial infarction(stemi), anemia and was hospitalized for the same.Serial troponins showed elevation.Coronary angiography was planned.The patient's medication regimen was adjusted in response to the event.Sixteen days after, the patient was discharged on acetyl salicylic acid.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that stent thrombosis occurred to the two 2.75x38mm and one 2.25x38mm synergy¿ drug-eluting stents and not restenosis as what was previously reported.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that in (b)(6) 2017, it was an unknown previously placed stent in rca that was treated with pre-dilatation and placement of two 3.50 x 38 mm synergy stents in an overlapping manner.Sixteen days after, in emergency, the patient had a mild elevation of troponin.The patient's brain natriuretic peptide (bnp) was found to be elevated and the patient was admitted to the hospital for congestive heart failure.

• 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: 6396639
• MDR Text Key: 69641282
• Report Number: 2134265-2017-01957
• 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: 02/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2017
• 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: 05/02/2017
• 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
• Patient Age: 75 YR