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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 10618
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Insufficient Information (4580)
Event Date 11/23/2020
Event Type  Death  
Event Description
It was reported that the patient expired.Six weeks earlier, a 4.00mm non-boston scientific stent was implanted to treat the 5.75mm in length target lesion located in the left main (lm) artery.The non- boston scientific stent was under expanded measuring only 4.5mm.In (b)(6) 2020, a percutaneous coronary intervention (pci) was performed.A 3.00 x 16 synergy stent was implanted in the left anterior descending artery (lad) without any issues.A 3.00mm x 24mm synergy drug-eluting stent was taken over the non-boston scientific wire and through the previously implanted 4.00mm non-boston scientific stent.The 3.00mm x 24mm synergy stent was deployed at the bifurcation of the lad and left circumflex artery (lcx).A stent boost was taken to see the proximal landing of the expanded synergy stent.At this time the patients pressure dropped and angio revealed a flow limiting dissection distal to the lcx and distal to the deployed stent.The resuscitation team and cardiac surgeon were called to treat the patient.That afternoon, the patient left the catheterization lab in stable condition.It was noted that the physician confirmed that the non-boston scientific wire caused the dissection.However, later that evening the patient passed away.The documented cause of death has not been provided.
 
Event Description
It was reported that the patient expired.Six weeks earlier, a 4.00mm non-boston scientific stent was implanted to treat the 5.75mm in length target lesion located in the left main (lm) artery.The non- boston scientific stent was under expanded measuring only 4.5mm.In (b)(6) 2020, a percutaneous coronary intervention (pci) was performed.A 3.00 x 16 synergy stent was implanted in the left anterior descending artery (lad) without any issues.A 3.00mm x 24mm synergy drug-eluting stent was taken over the non-boston scientific wire and through the previously implanted 4.00mm non-boston scientific stent.The 3.00mm x 24mm synergy stent was deployed at the bifurcation of the lad and left circumflex artery (lcx).A stent boost was taken to see the proximal landing of the expanded synergy stent.At this time the patients pressure dropped and angio revealed a flow limiting dissection distal to the lcx and distal to the deployed stent.The resuscitation team and cardiac surgeon were called to treat the patient.That afternoon, the patient left the catheterization lab in stable condition.It was noted that the physician confirmed that the non-boston scientific wire caused the dissection.However, later that evening the patient passed away.The documented cause of death has not been provided.
 
Manufacturer Narrative
H6 - patient codes: changed from death to insufficient information.H6 - impact codes: changed from none to death.
 
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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 Key10986043
MDR Text Key220751439
Report Number2134265-2020-17323
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 09/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/10/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date01/19/2022
Device Model Number10618
Device Catalogue Number10618
Device Lot Number0025096081
Was Device Available for Evaluation? No
Date Manufacturer Received09/01/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Death;
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