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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PROMUS ELITE; STENT, CORONARY, DRUG-ELUTING

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BOSTON SCIENTIFIC CORPORATION PROMUS ELITE; STENT, CORONARY, DRUG-ELUTING Back to Search Results
Model Number 10672
Device Problem Break (1069)
Patient Problem Foreign Body In Patient (2687)
Event Date 03/23/2022
Event Type  Death  
Event Description
It was reported that shaft break occurred and the patient died.Vascular access was obtained via femoral artery.The 98% stenosed, 50x25mm, eccentric and de novo target lesion with a bend of between 45 and 90 degrees was located in the severely tortuous and moderately calcified left anterior descending artery.After a 6f non-boston scientific (bsc) guide catheter and a 0.014 non-bsc guidewire crossed the lesion, pre-dilatation was performed with a 1.5 x 15 mm and 2.0x12mm balloon catheters leaving 98% residual stenosis.A 16 x 2.25 promus elite drug-eluting stent was advanced for treatment.However, during the procedure without any force or pressure, the stent's hypotube was cut.The procedure was completed; however, after the procedure, the patient died.
 
Event Description
It was reported that shaft break occurred and the patient died.Vascular access was obtained via femoral artery.The 98% stenosed, 50x25mm, eccentric and de novo target lesion with a bend of between 45 and 90 degrees was located in the severely tortuous and moderately calcified left anterior descending artery.After a 6f non-boston scientific (bsc) guide catheter and a 0.014 non-bsc guidewire crossed the lesion, pre-dilatation was performed with a 1.5 x 15 mm and 2.0x12mm balloon catheters leaving 98% residual stenosis.A 16 x 2.25 promus elite drug-eluting stent was advanced for treatment.However, during the procedure without any force or pressure, the stent's hypotube was cut.The procedure was completed; however, after the procedure, the patient died.It was further reported that there was no resistance encountered while removing the stent.The hypotube was cut outside the patient, so the device was removed from the remaining end with no material left inside the patient.
 
Manufacturer Narrative
D6a implant date: corrected.The promus elite ous mr 16 x 2.25mm stent delivery system was returned for analysis.A visual examination of the stent found no issues.There was no sign of damage, stretching or lifting of the stent struts.The stent showed no signs of movement and was set between the proximal and distal markerbands.The crimped stent outer diameter was measured within maximum crimped stent profile measurement.The balloon cones were reviewed, and no issues were noted.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.A visual and microscopic examination of the bumper tip showed no signs of damage.A visual and tactile examination of the hypotube shaft found a break situated at 20cm distal to the distal end of strain relief as well as multiple kinks along the length of the hypotube shaft.A visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found no issues along the shaft polymer extrusion.No other issues were identified during the product analysis.
 
Event Description
It was reported that shaft break occurred and the patient died.Vascular access was obtained via femoral artery.The 98% stenosed, 50x25mm, eccentric and de novo target lesion with a bend of between 45 and 90 degrees was located in the severely tortuous and moderately calcified left anterior descending artery.After a 6f non-boston scientific (bsc) guide catheter and a 0.014 non-bsc guidewire crossed the lesion, pre-dilatation was performed with a 1.5 x 15 mm and 2.0x12mm balloon catheters leaving 98% residual stenosis.A 16 x 2.25 promus elite drug-eluting stent was advanced for treatment.However, during the procedure without any force or pressure, the stent's hypotube was cut.The procedure was completed; however, after the procedure, the patient died.It was further reported that there was no resistance encountered while removing the stent.The hypotube was cut outside the patient, so the device was removed from the remaining end with no material left inside the patient.
 
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Brand Name
PROMUS ELITE
Type of Device
STENT, CORONARY, DRUG-ELUTING
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
ballybrit business park
galway
EI  
Manufacturer Contact
jay johnson
4100 hamline ave n
arden hills, MN 55112
6515810888
MDR Report Key13971947
MDR Text Key288349660
Report Number2134265-2022-03752
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeAR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 09/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/02/2023
Device Model Number10672
Device Catalogue Number10672
Device Lot Number0026797713
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/23/2022
Initial Date FDA Received03/31/2022
Supplement Dates Manufacturer Received04/27/2022
09/07/2022
Supplement Dates FDA Received04/29/2022
09/08/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/02/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
GUIDE CATHETER - 6F 3.5 EBU; GUIDE CATHETER - 6F 3.5 EBU; GUIDE CATHETER - 6F 3.5 EBU
Patient Outcome(s) Death;
Patient Age80 YR
Patient SexFemale
Patient Weight70 KG
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