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.

• Brand Name: SYNERGY
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• 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
• Reporter Country Code: MY
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri

Reporter Occupation

• 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

• 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
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/21/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/03/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 07/23/2020 Patient Sequence Number: 1