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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 10622
Device Problems Break (1069); Difficult to Remove (1528); Physical Resistance/Sticking (4012)
Patient Problems Chest Pain (1776); Dyspnea (1816); Edema (1820); Pulmonary Edema (2020); Tachycardia (2095); Thrombosis (2100)
Event Date 01/22/2019
Event Type  Injury  
Manufacturer Narrative
Device is combination product.
 
Event Description
It was reported that removal difficulty, shaft break, and acute thrombosis occurred.Vascular access was obtained via the femoral artery.The 70% stenosed, 38mmx3.5mm target lesion was located in a non-tortuous, mildly calcified right coronary artery.Pre-procedure, the patient was given 300mg aspirin and 300mg clopidogrel.Intra-procedure, the patient was given tirofiban.Following pre-dilatation with a 3.0x20mm non-bsc balloon, the stenosis remained at 50%.A total of four stents were implanted in the right coronary artery, including a 4.0x20mm synergy, 3.5x32mm synergy (complaint in question), 3.5x32mm synergy and a 3.5x38mm non-bsc stent.Post implant of the first 3.5 x 32mm synergy ii des stent, the balloon catheter was difficult to remove from the stent and also became stuck in the guiding catheter.The shaft of the balloon was also noted to be detached/separated.Both the guiding catheter and stent balloon catheter were safely removed from the patient.A new guiding catheter was used and the procedure was successfully completed.Post procedure, the patient developed chest pain associated with dyspnea.Electrocardiography was performed immediately which revealed sinus tachycardia and subtle changes of high side wall.It appeared ventilator failure was imminent so the patient was immediately returned to the cath lab with suspected acute stent thrombosis.There was appreciated thrombotic load, not occlusive.No stent deformation was noted.Further intervention was performed with intracoronary tirofiban and the patient is reported to be stable.
 
Event Description
It was reported that removal difficulty, shaft break, and acute thrombosis occurred.Vascular access was obtained via the femoral artery.The 70% stenosed, 38mmx3.5mm target lesion was located in a non-tortuous, mildly calcified right coronary artery.Pre-procedure, the patient was given 300mg aspirin and 300mg clopidogrel.Intra-procedure, the patient was given tirofiban.Following pre-dilatation with a 3.0x20mm non-bsc balloon, the stenosis remained at 50%.A total of four stents were implanted in the right coronary artery, including a 4.0x20mm synergy, 3.5x32mm synergy (complaint in question), 3.5x32mm synergy and a 3.5x38mm non-bsc stent.Post implant of the first 3.5 x 32mm synergy ii des stent, the balloon catheter was difficult to remove from the stent and also became stuck in the guiding catheter.The shaft of the balloon was also noted to be detached/separated.Both the guiding catheter and stent balloon catheter were safely removed from the patient.A new guiding catheter was used and the procedure was successfully completed.Post procedure, the patient developed chest pain associated with dyspnea.Electrocardiography was performed immediately which revealed sinus tachycardia and subtle changes of high side wall.It appeared ventilator failure was imminent so the patient was immediately returned to the cath lab with suspected acute stent thrombosis.There was appreciated thrombotic load, not occlusive.No stent deformation was noted.Further intervention was performed with intracoronary tirofiban and the patient is reported to be stable.
 
Manufacturer Narrative
Device is combination product.A 3.50 x 32 mm synergy stent delivery system was returned for analysis.Based on the potential root causes identified in the fmea and the complaint report, the following attributes were examined: the stent was not returned for analysis.The complaint report stated that the stent was deployed in the patients body.The balloon cones were reviewed; no issues were noted on the balloon.It was evident that the balloon was subjected to negative pressure as it was in a flattened deflated state which is consistent with device use.Crimp marking were also evident on exposed balloon wall indicating that the stent was crimped to the balloon prior to deployment.A visual and microscopic examination of the bumper tip showed signs of damage on the distal edges of the tip.Tip damage most likely occurred when the tip was pushed against a restriction.A visual and tactile examination of the hypotube found multiple kinks along several locations of the hypotube shaft.This type of damage is consistent with excessive force that could have been applied on the delivery system.A tactile examination of the inner and visual and tactile examination of the outer and mid-shaft section found that the mid-shaft was broken at 118.6 cm distal from the distal end of the strain relief.Shaft polymer extrusion was also noted to be stretched and damaged.The types of damage noted are consistent with excessive force that could have been applied on the delivery system.
 
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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 Key8362582
MDR Text Key136893578
Report Number2134265-2019-01610
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 04/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/22/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/22/2019
Device Model Number10622
Device Catalogue Number10622
Device Lot Number22327756
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/07/2019
Date Manufacturer Received03/28/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age74 YR
Patient Weight61
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