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Model Number H7493919838350
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. 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 2134265-2017-07978, 2134265-2017-07980, 2134265-2017-07979, and 2134265-2017-07982. It was reported that vessel dissection and ventricular fibrillation occurred. The patient presented with exertional angina pectoris. A synergy3. 0x28mm was implanted in the proximal right coronary artery (rca) and a synergy2. 25x38mm 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. 0x10mm cutting balloon and observed using ivus. Since the re-entry was not sufficient, dilatation was performed again using a 3. 5x10mm 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. 0x38mm, 3. 5x38mm, and 3. 5x24mm) 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 synergy3. 5x16mm 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.
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Brand NameSYNERGY¿
Manufacturer (Section D)
Manufacturer (Section G)
Manufacturer Contact
sonali arangil
one scimed place
maple grove, MN 55311
MDR Report Key6771754
MDR Text Key82004626
Report Number2134265-2017-07981
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
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 Received08/07/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberH7493919838350
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/20/2017
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

Patient Treatment Data
Date Received: 08/07/2017 Patient Sequence Number: 1