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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 10617
Device Problems Device Dislodged or Dislocated (2923); Activation Failure (3270); Migration (4003)
Patient Problems No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165)
Event Date 01/25/2019
Event Type  Injury  
Manufacturer Narrative
Device is a combination product.(b)(6).
 
Event Description
It was reported that stent insufficient apposition and stent dislodgment occurred.A 4.00 x 12 synergy stent was used to treat a dissection located in the moderately tortuous and mildly calcified proximal right coronary artery.Intravascular ultrasound revealed that the distal blood vessel inner diameter was 3.5x4.8mm and the proximal was more than 5.0mm, complete apposition could not be performed in the proximal end of the stent.The delivery system was dilated at 12 atmospheres subsequent to stent deployment, the delivery system was pulled back and the stent also moved proximally.The stent was pushed together with the delivery system, back to its original position and the delivery system disengaged.However, the stent migrated and lodged within the gluteal region of the internal iliac artery, which was confirmed via cine and computerized tomography.No intervention was performed to retrieve the stent.No further patient complications were reported and the patient's status was good.
 
Manufacturer Narrative
Device is a combination product.Initial reporter facility name: (b)(6).Correction: device code device dislodged or dislocated was changed to migration.Device evaluated by mfr.: synergy ous mr 4.00 x 12mm stent delivery catheter (sdc) was returned for analysis without a stent.The balloon was examined under scope.It was evident that the balloon had been inflated and deflated, the balloon was in a flattened deflated state.There was evidence of clear dried media inside balloon.There was no damage noted to the balloon.The device was loaded onto a 0.014" guidewire.Positive pressure was applied using encore inflation device and the balloon inflated with no issues to rated burst pressure.A vacuum was pulled and the balloon deflated successfully within the deflation time specifications.There were no issues noted during balloon inflation or deflation.There were no leaks in the balloon.Inflation device was verified before and after testing using druck pressure gauge.A visual and tactile examination of shaft polymer extrusion found no issues.A visual and tactile examination of the hypotube found multiple hypotube kinks.A visual and microscopic examination of the tip found no issues.No other issues were identified during the product analysis.
 
Event Description
It was reported that stent insufficient apposition and stent dislodgment occurred.A 4.00 x 12 synergy stent was used to treat a dissection located in the moderately tortuous and mildly calcified proximal right coronary artery.Intravascular ultrasound revealed that the distal blood vessel inner diameter was 3.5x4.8mm and the proximal was more than 5.0mm, complete apposition could not be performed in the proximal end of the stent.The delivery system was dilated at 12 atmospheres subsequent to stent deployment, the delivery system was pulled back and the stent also moved proximally.The stent was pushed together with the delivery system, back to its original position and the delivery system disengaged.However, the stent migrated and lodged within the gluteal region of the internal iliac artery, which was confirmed via cine and computerized tomography.No intervention was performed to retrieve the stent.No further patient complications were reported and the patient's status was good.
 
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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 Key8353840
MDR Text Key136630308
Report Number2134265-2019-01364
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,distri
Type of Report Initial,Followup
Report Date 03/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/20/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/10/2019
Device Model Number10617
Device Catalogue Number10617
Device Lot Number22162878
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/12/2019
Date Manufacturer Received03/06/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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