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

Model Number H7493926238270

Device Problem Occlusion Within Device (1423)

Patient Problems Chest Pain (1776); Dyspnea (1816); Reocclusion (1985)

Event Date 06/07/2018

Event Type  Injury  

Manufacturer Narrative

Age at time of event: 18 years or older.  device evaluated by mfr: it is indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.  (b)(4).

Event Description

It was reported that in-stent restenosis (isr) occurred.In (b)(6) 2017, a 2.75 x 38mm synergy¿ drug-eluting stent was implanted in a moderately tortuous and mildly calcified obtuse marginal branch (om).In (b)(6) 2018, the patient presented with shortness of breath and mild chest pain and was admitted to the hospital.Vascular access was obtained via the right femoral artery.During re-intervention, the physician noted that the patient had developed isr.The physician then proceeded to wire down the vessel and percutaneous transluminal coronary angioplasty was performed to maintain flow in the artery.The procedure was successfully completed.The physician mentioned that the patient did not take his medication as prescribed.No further patient complications were reported.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that the patient's status was stable after medical intervention.

• 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: 7597794
• MDR Text Key: 110998345
• Report Number: 2134265-2018-05753
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: ZA
• 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
• Report Date: 06/07/2018

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: H7493926238270
• Device Catalogue Number: 39262-3827
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/07/2018
• Initial Date FDA Received: 06/13/2018
• Supplement Dates Manufacturer Received: 06/07/2018
• Supplement Dates FDA Received: 07/02/2018
• 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