MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM

Device Problem Obstruction of Flow (2423)

Patient Problem Reocclusion (1985)

Event Date 08/01/2018

Event Type  Injury  

Manufacturer Narrative

Hidekazu aoyama, et.Al., "midterm results after implantation of the 3rd generation des in our hospital and a study of in-stent covering by using oct." 2018-08-02, 9:45-10:45, 9, 4f 402.Device is combination product date of death and date of event: unknown, estimated as first day of publication month.(b)(6).

Event Description

It was reported via journal article that stent thrombosis occurred.This study enrolled 209 drug eluting stent patients (91 fast-release zotarolimus-eluting stents (zess), 40 slow-release zess, 37 durable polymer cobalt-chromium (cocr) everolimus-eluting stents (eess), 4 durable polymer platinum-chromium (ptcr) eess, 25 bioresorbable polymer ptcr eess (synergy), 12 bioresorbable polymer cocr sirolimus-eluting stents) from 135 patients (male 83%, age 69 plus or minus 10 years).They evaluated predictors for intra-stent thrombus by coronary angioscopy 4 months plus or minus 1 month after the implantation.Intra-stent thrombus was observed in 65 stents (31%).Multivariate analysis demonstrated that dyslipidemia, hemodialysis and fast-release zes implantation were associated with presence of intra stent thrombus.This result may indicate the need of dual antiplatelet therapy (dapt) continuation beyond 4 months for patients with hemodialysis and dyslipidemia, whereas we may safely switch dapt to single antiplatelet therapy in early phase for patients treated with fast-release zes.

• Brand Name: SYNERGY
• Type of Device: BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8536054
• MDR Text Key: 142636068
• Report Number: 2134265-2019-04083
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 04/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other