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

Model Number H7493926232220

Device Problem Occlusion Within Device (1423)

Patient Problems Chest Pain (1776); Hypersensitivity/Allergic reaction (1907); Reocclusion (1985)

Event Type  Injury  

Manufacturer Narrative

Age at time of event: (b)(6).Event date: (b)(6) 2016.Device is a combination product.The complaint device was not returned for analysis.The investigation conclusion is anticipated procedural complication as the event is due to a known physiological effect of the procedure noted within the directions for use, and/or device labeling.(b)(4).

Event Description

It was reported that chest pain, in-stent restenosis (isr), and allergic reaction occurred.In (b)(6) 2014, a non-bsc stent was implanted in the mid left anterior descending (lad) artery.In (b)(6) 2015, isr was found in the previously implanted stent and in response, dilatation was performed using a drug coated balloon (dcb).In (b)(6) 2016, isr was observed again which was treated with the implantation of a 2.25 x 32 synergy¿ drug-eluting stent.In (b)(6) 2016, the patient complained of chest pain and occlusion was found in the mid lad.It was noted that the patient also has a stent placed in the mid right coronary artery (rca).Since isr has been reoccurring, metal allergy was suspected.Metal patch test was performed and it was confirmed that the patient was allergic to six kinds of metal including nickel.In (b)(6) 2016, isr was observed again.It was determined that further stent placement would be difficult due to the recurring restenosis caused by the patient's metal allergy; therefore, coronary artery bypass grafting was performed.In (b)(6) 2017, patient was discharged from the hospital.No further patient complications were reported and the patient's status was stable.

• 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: 7028915
• MDR Text Key: 91939779
• Report Number: 2134265-2017-11230
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• 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
• Report Date: 10/27/2017

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: H7493926232220
• Device Catalogue Number: 39262-3222
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/27/2017
• Initial Date FDA Received: 11/14/2017
• 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; Required Intervention