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

Model Number H7493926216400

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

Patient Problems Cardiac Enzyme Elevation (1838); Fatigue (1849); Myocardial Infarction (1969); Pain (1994); Dizziness (2194)

Event Date 05/12/2017

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.The device was not received 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

(b)(4) clinical study.It was reported that myocardial infarction (mi) occurred.In (b)(6) 2017, the index procedure was performed and a synergy¿ drug-eluting stent was implanted for treatment.However, post index procedure, cardiac enzymes were noted to be elevated and an event of periprocedure mi was reported.The outcome of the event is not recovered.

Manufacturer Narrative

Age at time of event, age at time of event (unit), patient sex, describe event or problem, other relevant history, catalog/model #, device lot number, device expiration date, device manufactured date updated.(b)(4).

Event Description

It was further reported that in (b)(6) 2017, clinical status assessment indicated the patient's qualifying condition as stable angina and the index procedure was performed.The target lesion was located in the proximal left anterior descending (lad) artery with 90% stenosis and was 11mm long with a reference vessel diameter of 4.0mm.The target lesion was treated with pre-dilatation and placement of a 4.00 x 16 synergy¿ drug-eluting stent.Following post-dilatation, there was 5% residual stenosis.Three days later the patient was discharged on dual antiplatelet therapy.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that during the index procedure following post dilatation, the timi flow was 3.Post index procedure, the patient was ordered for repeat angiography, electrocardiogram (ecg) and lab examination.The patient was kept under clinical observation of pain and support.Ecg revealed no abnormalities.In addition, the patient also underwent coronary angiography which revealed occlusion of the diagonal branch.During the stay in the hospital, the patient was noted with fatigue associated with dizziness while walking.Three days later, the patient was found to be hemodynamically stable with improvement in pain and was discharged on antiplatelet therapy.

• 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: 6602631
• MDR Text Key: 76316719
• Report Number: 2134265-2017-05629
• 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,Followup
• Report Date: 05/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/15/2017
• Device Model Number: H7493926216400
• Device Catalogue Number: 39262-1640
• Device Lot Number: 18953583
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2016
• 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): Other
• Patient Age: 83 YR