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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY; CORONARY DRUG-ELUTING STENT
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BOSTON SCIENTIFIC CORPORATION SYNERGY; CORONARY DRUG-ELUTING STENT Back to Search Results
Model Number 10632
Device Problems Positioning Failure (1158); Material Rupture (1546)
Patient Problem Embolism/Embolus (4438)
Event Date 01/28/2021
Event Type  Injury  
Event Description
It was reported that balloon rupture, stent foreshortening and embolization occurred.Vascular access was obtained via the radial artery.The 48mm in length, de novo target lesion containing <=45 degrees bend was located in the mildly tortuous right coronary artery (rca).A 2.75 x 48 synergy drug-eluting stent was advanced for treatment.However, during stent deployment, the balloon ruptured not allowing the stent to open, followed by a rupture of the catheter at the level of its distal segment.The undeployed and shortened stent that was mounted on the stretched balloon blocked the level of the rca.Attempts to hang the balloon with two guides mounted like a snare, followed by attempts to pass support guides behind the stent failed, justifying the urgent need for surgery.
 
Event Description
It was reported that balloon rupture, stent foreshortening and embolization occurred.Vascular access was obtained via the radial artery.The 48mm in length, de novo target lesion containing <=45 degrees bend was located in the mildly tortuous right coronary artery (rca).A 2.75 x 48 synergy drug-eluting stent was advanced for treatment.However, during stent deployment, the balloon ruptured not allowing the stent to open, followed by a rupture of the catheter at the level of its distal segment.The undeployed and shortened stent that was mounted on the stretched balloon blocked the level of the rca.Attempts to hang the balloon with two guides mounted like a snare, followed by attempts to pass support guides behind the stent failed, justifying the urgent need for surgery.
 
Manufacturer Narrative
Eval by mfr: the device was not returned for analysis however a video of an angiographic recording was received attached together with the cnf of this complaint.Media analysis: a media video clip was received and contained 6 seconds long recording of angiographic images taken during the procedure.A guide catheter was in position in rca and contrast flow assessment highlights a stent positioned in the mid to proximal region of this coronary artery.Flow contrast is noted to be leaking from the proximal region of the delivery system as a bulge is noted during attempts to inflate the positioned stent.Additionally the distal and proximal regions of the delivery system balloon appear partially inflated and a previously deployed stent is noted in the mid region of rca with this partially deployed stent overlapping it.The media provided confirms the alleged stent profile problem as a partially expanded stent positioned in rca was noted.This partial expansion of the stent occurred most likely due to the insufficient pressure built up in the delivery balloon to allow for it to inflate and expand the stent.The cause of this loss of pressure was most likely related to the alleged balloon damage/ rupture which was observed during the media review as an accumulation of fluid (bulge) visible proximally to the positioned stent during inflation attempts.
 
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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 Key11337629
MDR Text Key232177420
Report Number2134265-2021-01369
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 04/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/17/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/17/2021
Device Model Number10632
Device Catalogue Number10632
Device Lot Number0024849175
Was Device Available for Evaluation? No
Date Manufacturer Received03/22/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
GUIDE CATHETER: CONVEY JR4; GUIDE CATHETER: CONVEY JR4; GUIDEWIRE: PT2 0.014; GUIDEWIRE: PT2 0.014; GUIDE CATHETER: CONVEY JR4; GUIDEWIRE: PT2 0.014
Patient Outcome(s) Other;
Patient Age48 YR
Patient Weight80
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