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

Model Number 10619

Device Problems Fracture (1260); Migration (4003)

Patient Problems Insufficiency, Valvular (1926); Pulmonary Edema (2020); Prolapse (2475); Aortic Dissection (2491); No Code Available (3191)

Event Date 06/15/2020

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.

Event Description

It was reported that aortic dissection, pulmonary edema and stent fracture occurred.The patient presented within 1 hour of onset of acute central chest pain.She was in shock, blood pressure(bp) 78/50, heart rate 80 regular with no discrepancy of bps from left and right arms.There were no signs of pulmonary edema.Emergent coronary angiogram revealed two target lesions.One lesion was a discrete ostial stenosis of 50-60% in the left main stem(lms) and the second lesion was a discrete ostial and proximal stenosis of 70% in the right coronary artery(rca).A 4.00 x 16 synergy drug eluting stent was implanted in the lms and a 4.00 x 20 synergy drug eluting stent was implanted in the rca.On table echocardiogram showed mild hypokinesia in the interventricular septum(ivs) and anterior walls.Color doppler assessment of the valves was not performed but angiographic findings suggested mild aortic regurgitation.Percutaneous coronary intervention(pci) to both lms and rca was performed successfully with no immediate complications.The patient was weaned off inotropic support within 12 hours.However, three hours post pci the patient developed pulmonary edema.An echocardiogram was performed and revealed severe aortic regurgitation (likely acute with no left ventricular dilatation), a possible dissection flap in the right sinus of valsalva and possible migration of the right coronary stent into the right sinus of valsalva.Left ventricular ejection fraction(lvef) was 45-50%, same as pre-pci finding.The patient was then transferred to another hospital for aortic valve, aortic root and ascending aorta repair.Intraoperative findings included spiral dissection in the root and ascending aorta, originating from the left and right coronary ostia; severe prolapse of the aortic cusps and both stents protruded about 1cm into the sinus.Lastly, both stents were surgically removed and appeared cracked and broken after removal from the coronary arteries.The patient had aortic valve replacement and was doing well post procedure.

Manufacturer Narrative

Device analysis: two stents were returned in a jar (synergy ous mr 4.00 x 16 and synergy ous mr 4.00 x 20).No delivery system was returned.It was not possible to distinguish between the 2 stents because accurate dimensions could not be measured due to damage to the stents and the stent segments/peaks could not be counted.Both stents appeared to be in expanded conformation and severely deformed with struts stretched and bunched.Both stents appeared to have a blood like substance on them consistent with stent being inside the patient.One of the stents had fractured struts at one end of the stent.Angiographic media review: narrowings were evident in the left main (lm) and right coronary artery (rca) ostia.Pre-dilation was carried out in the ostial-proximal lm.Some flow improvement was noted following pre-dilation however narrowing was still evident in the lm ostium.A stent was positioned in the lm; the proximal end of the stent appeared to be aligned closely to or partially extending into with the lm ostium.The stent was deployed with the balloon appearing to expand fully.The stent delivery system was then removed.Multiple post-dilations were carried out in the proximal end of the stent (in the lm ostium) using a two markerband balloon.This balloon was of shorter length and wider diameter than the stent delivery balloon.The stent appeared successfully deployed is the vessel with a constriction in the stent where the stent appeared to have conformed to lesion shape.Flow through the ostial-proximal lm appeared to have been approved.Following pre-dilation in the ostial-proximal rca, significant narrowing was still evident.A stent was deployed in ostial-proximal rca with the balloon appearing to expand fully.Multiple post-dilations were carried out in the proximal end of the stent in the rca ostium using a two markerband balloon.This balloon was of shorter length and wider diameter than the stent delivery balloon.In the final series the stent appeared to have been successfully deployed with restored flow through the ostial rca.The media review was consistent with the event description including the presence of ostial lesions in lm and rca and the deployment of stents in these locations.Per the event description angiographic findings suggested mild aortic regurgitation and during review of the media mild aortic regurgitation was evident at the beginning and end of the procedure.There was no evidence in the media of any stent deformation or fracture.In the series and view provided the stents appeared well apposed with no evidence of stent migration and no issues noted which could have contributed to stent migration post procedure.The reported events which occurred three hours post pci could not be confirmed by the media as they occurred after the media concluded.It was noted in the media review that no intravascular ultrasound device was present in any of the series provided and therefore it did not appear that ivus assessment was carried out, it was also stated in the cnf that ivus was not used, however the use of ivus in this complex ostial and lm case may have provided better lesion assessment that angiogram alone.

Event Description

It was reported that aortic dissection, pulmonary edema and stent fracture occurred.The patient presented within 1 hour of onset of acute central chest pain.She was in shock, blood pressure(bp) 78/50, heart rate 80 regular with no discrepancy of bps from left and right arms.There were no signs of pulmonary edema.Emergent coronary angiogram revealed two target lesions.One lesion was a discrete ostial stenosis of 50-60% in the left main stem(lms) and the second lesion was a discrete ostial and proximal stenosis of 70% in the right coronary artery(rca).A 4.00 x 16 synergy drug eluting stent was implanted in the lms and a 4.00 x 20 synergy drug eluting stent was implanted in the rca.On table echocardiogram showed mild hypokinesia in the interventricular septum(ivs) and anterior walls.Color doppler assessment of the valves was not performed but angiographic findings suggested mild aortic regurgitation.Percutaneous coronary intervention(pci) to both lms and rca was performed successfully with no immediate complications.The patient was weaned off inotropic support within 12 hours.However, three hours post pci the patient developed pulmonary edema.An echocardiogram was performed and revealed severe aortic regurgitation (likely acute with no left ventricular dilatation), a possible dissection flap in the right sinus of valsalva and possible migration of the right coronary stent into the right sinus of valsalva.Left ventricular ejection fraction(lvef) was 45-50%, same as pre-pci finding.The patient was then transferred to another hospital for aortic valve, aortic root and ascending aorta repair.Intraoperative findings included spiral dissection in the root and ascending aorta, originating from the left and right coronary ostia; severe prolapse of the aortic cusps and both stents protruded about 1cm into the sinus.Lastly, both stents were surgically removed and appeared cracked and broken after removal from the coronary arteries.The patient had aortic valve replacement and was doing well post procedure.

• Brand Name: SYNERGY
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10312864
• MDR Text Key: 200067128
• Report Number: 2134265-2020-09227
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 09/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/02/2021
• Device Model Number: 10619
• Device Catalogue Number: 10619
• Device Lot Number: 0024942777
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2020
• Date Manufacturer Received: 08/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 45 YR