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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 10621
Device Problems Break (1069); Failure to Advance (2524); Material Integrity Problem (2978)
Patient Problems Vascular Dissection (3160); Device Embedded In Tissue or Plaque (3165); No Code Available (3191)
Event Date 09/10/2019
Event Type  Injury  
Manufacturer Narrative
Device is a combination product.
 
Event Description
It was reported that difficulty crossing a lesion, shaft damage, shaft break, and device fragment remaining in patient occurred.A 3.00 x 28 synergy stent was advanced to the right coronary artery, but was not able to cross the lesion.On the second attempt, the stent became stuck in the proximal right coronary artery, first diagonal segment, and the stent shaft broke.The distal part of the stent, the stent balloon, and about 7cm of the shaft remained inside the patient, where approximately 15 mm of the stent protruded into the aorta.The patient was then transferred to another hospital for removal of the remaining material, but the attempt to remove the material was not successful.About ten days later, the patient had a coronary bypass on the right coronary artery, where the part of the stent which protruded into the aorta could be cut and removed.However, there was still a part of the stent (15mm) that protruded into the aorta as well as approximately 7cm of the radiotranslucent shaft.No patient complications were reported in relation to this event and the patient was reported to be okay and stable.
 
Event Description
It was reported that difficulty crossing a lesion, shaft damage, shaft break, and device fragment remaining in patient occurred.A 3.00 x 28 synergy stent was advanced to the right coronary artery, but was not able to cross the lesion.On the second attempt, the stent became stuck in the proximal right coronary artery, first diagonal segment, and the stent shaft broke.The distal part of the stent, the stent balloon, and about 7cm of the shaft remained inside the patient, where approximately 15 mm of the stent protruded into the aorta.The patient was then transferred to another hospital for removal of the remaining material, but the attempt to remove the material was not successful.About ten days later, the patient had a coronary bypass on the right coronary artery, where the part of the stent which protruded into the aorta could be cut and removed.However, there was still a part of the stent (15mm) that protruded into the aorta as well as approximately 7cm of the radiotranslucent shaft.No patient complications were reported in relation to this event and the patient was reported to be okay and stable.It was further reported that a fracture of a balloon catheter shaft holding a 3 x28mm synergy active stent occurred during an extraction attempt.The stent was stuck in the proximal right coronary (long restenosis complex lesion).Initial procedure extended due to an unsuccessful attempt of extracting the device.The patient was transferred the same day to another facility.New extraction attempt was made the next day, very extended, and still unsuccessful.X ray done on (b)(6) 2019 showed a dissection of the proximal right coronary and the aortic root.On (b)(6) 2019 a surgical intervention was attempted by sternotomy single bypass of the right coronary, aortic root repaired (glued).The device was partially extracted.
 
Manufacturer Narrative
Device is a combination product.
 
Event Description
It was reported that difficulty crossing a lesion, shaft damage, shaft break, and device fragment remaining in patient occurred.A 3.00 x 28 synergy stent was advanced to the right coronary artery, but was not able to cross the lesion.On the second attempt, the stent became stuck in the proximal right coronary artery, first diagonal segment, and the stent shaft broke.The distal part of the stent, the stent balloon, and about 7cm of the shaft remained inside the patient, where approximately 15 mm of the stent protruded into the aorta.The patient was then transferred to another hospital for removal of the remaining material, but the attempt to remove the material was not successful.About ten days later, the patient had a coronary bypass on the right coronary artery, where the part of the stent which protruded into the aorta could be cut and removed.However, there was still a part of the stent (15mm) that protruded into the aorta as well as approximately 7cm of the radiotranslucent shaft.No patient complications were reported in relation to this event and the patient was reported to be okay and stable.It was further reported that a fracture of a balloon catheter shaft holding a 3 x28mm synergy active stent occurred during an extraction attempt.The stent was stuck in the proximal right coronary (long restenosis complex lesion).Initial procedure extended due to an unsuccessful attempt of extracting the device.The patient was transferred the same day to another facility.New extraction attempt was made the next day, very extended, and still unsuccessful.X ray done on (b)(6) 2019 showed a dissection of the proximal right coronary and the aortic root.On (b)(6) 2019 a surgical intervention was attempted by sternotomy single bypass of the right coronary, aortic root repaired (glued).The device was partially extracted.
 
Manufacturer Narrative
Device is a combination product.Device evaluated by mfr: synergy ous mr 3.00 x 28 mm stent delivery system was returned for analysis without the polymer extrusion shaft, balloon or stent.A visual and tactile examination of the hypotube found multiple severe kinks and a break on the laser-cut region 120.2cm distal to the distal end of the strain relief.The core-wire and tab exposed at the break site.No other issues were identified during the product analysis.
 
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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 Key9292471
MDR Text Key165548941
Report Number2134265-2019-13403
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,Followup
Report Date 01/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/07/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number10621
Device Catalogue Number10621
Device Lot Number0024027547
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/20/2019
Date Manufacturer Received12/16/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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