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

Model Number H7493926228300

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

Patient Problems Intimal Dissection (1333); ST Segment Elevation (2059); Ventricular Fibrillation (2130)

Event Type  Injury  

Manufacturer Narrative

Device is combination product.Device evaluated by mfr: it is indicated that the device will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.A review of the batch history, historical trending and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

Same case as mdr 2134265-2017-07979, 2134265-2017-07980, 2134265-2017-07981, and 2134265-2017-07982.It was reported that vessel dissection and ventricular fibrillation occurred.The patient presented with exertional angina pectoris.A synergy 3.0 x 28 mm was implanted in the proximal right coronary artery (rca) and a synergy 2.25 x 38 mm was implanted in the atrioventricular branch.On the final fluoroscopy, blood flow was observed and confirmed to be good.The procedure was completed and the patient was returned to the ward.After about an hour and a half, a heartbeat of 40 beats/minute and st elevation were noted.Transient ventricular fibrillation (avf) emerged and since consciousness level was decreasing, endotracheal intubation was performed.Under 12-lead electrocardiogram, st elevation was observed at ii, iii, and avf.Acute stent thrombosis was suspected, so emergency angiography was performed in the coronary artery.When the patient entered the catheterization room, st elevation on ii, iii, avf was found to be improved at 12-lead electrocardiogram.During coronary artery fluoroscopy, dissection of the coronary artery was found from the middle part of the implanted stent in the proximal rca up to the proximal part of the implanted stent in atrioventricular branch.Percutaneous coronary intervention (pci) was performed on the same area.A non-bsc guide catheter was introduced.The guidewire was crossed and an intravascular ultrasound (ivus) check was performed.The wire passed through the true lumen and dissection lumen was confirmed.In order to create re-entry of dissection, dilatation was performed using a 3.0 x 10 mm cutting balloon and observed using ivus.Since the re-entry was not sufficient, dilatation was performed again using a 3.5 x 10 mm cutting balloon and observed using ivus.The hematoma was reduced and re-entry was successful.Difficulty was encountered delivering a stent, so a non-bsc support catheter was used over the rca mid atrioventricular branch.Three synergy stents (3.0 x 38 mm, 3.5 x 38 mm, and 3.5 x 24 mm) were placed up to the stent in the proximal rca.At the fluoroscopy check, a reserve of contrast media was found at the ostium of the proximal rca.Since dissection of the ostium was suspected, a synergy 3.5 x 16 mm was placed.The stent was confirmed to be inflated sufficiently using an ivus check and the procedure was completed.The observations were good after the procedure and the patient was discharged eleven days later.

• 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: 6771719
• MDR Text Key: 81974069
• Report Number: 2134265-2017-07978
• 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: 07/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: H7493926228300
• Device Catalogue Number: 39262-2830
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2017
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR