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

Model Number	10607
Medical Device Problem Codes	Material Deformation (2976); Migration (4003)
Health Effect - Clinical Code	Ventricular Tachycardia (2132)
Date of Event	10/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a combination product.Date of event: used the 1st day of the month of the bsc aware date since event date was not provided.
Event or Problem Description
It was reported that stent migration occurred and patient experienced ventricular tachycardia.A 3.50 x 38mm synergy drug-eluting stent was implanted in the proximal left anterior descending artery and left main artery.A 4.0x20mm nc balloon catheter was used to post-dilate the stent and a non-bsc heart pump device was also placed.Angiography shows that the stent was patent.A few days later, the patient experienced ventricular tachycardia and was rushed to the cath lab.The stents that were placed were open.The patient remained in the intensive care unit and continued to have some issues.An echocardiogram was then performed which revealed that the 20mm of the synergy stent was hanging into the aorta.The stent was snared successfully.The patient already had low ejection fraction and a left ventricular assist device was given.The physician noted that the artery was still open and there was no further plan to do additional stenting.No further patient complications were reported and the patient was being monitored.
Additional Manufacturer Narrative
Device is a combination product.B3 date of event: used the 1st day of the month of the bsc aware date since event date was not provided.Device evaluated by mfr.: a media clip and imaging was received and reviewed.The video clip appeared to show a long crimped stent (consistent with a synergy ii des 3.50x38mm) being positioned in the lad, the proximal end of the stent was in the lad ostium.The distal end of the guide catheter had been deep seated into the lm and was positioned at the lad ostium.Guidewires were seen in both the lad and lcx.What appeared to be an impella device was evident in the heart.The still angiographic image showed two inflated balloons on guidewires; one in the lm to lad and one in the lm to lcx.This was consistent with balloon post dilation.The impaella device was again evident in the heart.The image was not clear enough the see the stent or its positioning.The media provided was consistent with statements in the event that the stent was deployed in the lm to lad and was post-dilated.However, as the video clip of the stent positioning did not show stent deployment and the still image of post dilation was not clear enough to make out the stent profile.Two photographs of the stent were reviewed after it had been removed from the patient.Both photographs showed what appeared to be a damaged stent attached to a snare device.The image magnification was not high enough to see the individual stent struts.H3 other text : media review.
Event or Problem Description
It was reported that stent migration occurred and patient experienced ventricular tachycardia.A 3.50 x 38mm synergy drug-eluting stent was implanted in the proximal left anterior descending artery and left main artery.A 4.0x20mm nc balloon catheter was used to post-dilate the stent and a non-bsc heart pump device was also placed.Angiography shows that the stent was patent.A few days later, the patient experienced ventricular tachycardia and was rushed to the cath lab.The stents that were placed were open.The patient remained in the intensive care unit and continued to have some issues.An echocardiogram was then performed which revealed that the 20mm of the synergy stent was hanging into the aorta.The stent was snared successfully.The patient already had low ejection fraction and a left ventricular assist device was given.The physician noted that the artery was still open and there was no further plan to do additional stenting.No further patient complications were reported and the patient was being monitored.

• Brand Name: SYNERGY
• Common Device Name: BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9236623
• Report Number: 2134265-2019-12886
• Device Sequence Number: 1564944
• Product Code: NIQ
• UDI-Device Identifier: 08714729840428
• UDI-Public: 08714729840428
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 10607
• Device Catalogue Number: 10607
• Device Lot Number: 0024060256
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/08/2019
• Supplement Date Received by Manufacturer: 10/21/2019
• Initial Report FDA Received Date: 10/24/2019
• Supplement Report FDA Received Date: 11/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention