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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 Problems Positioning Failure (1158); Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Patient Problems Angina (1710); Non specific EKG/ECG Changes (1817); Ischemia (1942); Myocardial Infarction (1969); Foreign Body In Patient (2687)
Event Date 04/12/2022
Event Type  Death  
Event Description
It was reported that a patient death occurred.A percutaneous transluminal coronary angioplasty (ptca) was performed on a radius intermedius and left anterior descending target lesion for a patient for acute myocardial infarction.A 8 x 2.50 promus elite mr stent was successfully deployed in the radius intermedius.A 16 x 2.50 promus elite mr stent was then deployed in the radius intermedius.Removal difficulties were encountered during withdrawal attempts of the deflated stent delivery balloon.A 12 x 2.75 promus elite mr stent and an 8 x 3.00 promus elite mr stent were deployed in the left anterior descending artery (lad) with success.Angiography was performed in a different coronary plane.Another lesion was observed in the ramus intermedius.A 16 x 2.50 promus elite mr stent was deployed in the ramus intermedius lesion, proximal to the first two drug eluting stents (2.5 x 8mm promus elite stent and 16 x 2.50 mm promus elite stent).The 16 x 2.50 promus elite mr was deployed at 14 atmospheres overlapping one of the previously placed promus elite stents.The angiography indicated that at one place or location the stent was not fully inflated.The 16 x 2.50 promus elite mr stent delivery balloon was deflated and inflated up to 14 atmospheres several times.Due to the vessel size, it was not possible to apply a higher pressure.The 16 x 2.50 promus elite mr stent was still not fully inflated.A non-compliant (nc) balloon was used in attempt to withdraw the 6 x 2.50 promus elite mr delivery balloon and to post dilate the 6 x 2.50 promus elite mr.It was not possible to mobilize the stent delivery balloon despite using the non-compliant (nc) balloon.The balloon on the 6 x 2.50 promus elite mr tore off the catheter.Subsequently, there was no blood flow into the vessel.The patient experienced angina pectoris and ecg changes were noticed.The patient was intubated for transportation.The patient had to be transferred for an emergency coronary artery bypass surgery.Following bypass surgery, the patient passed away due to heart failure on the intensive care unit.
 
Manufacturer Narrative
Device technical analysis: the device was not returned to the complaint investigation site and therefore device analysis could not be completed.Media review: procedural angiographic media was provided to assist in the investigation and was reviewed by a boston scientific medical director.The review highlighted the following relating to the placement of this complaint device: acute myocardial infarction presenting with severe three-vessel coronary artery disease.The culprit vessel was in a heavily calcified, tortuous ramus intermedius artery.Difficulty was encountered advancing interventional equipment into the ramus through the calcification and tortuosity.The sds (ref.Tw (b)(4)) appeared stuck for 15 minutes after a stent was placed in the proximal ramus.As two sequential lad stenoses were treated, threatened acute closure at the unstented ramus ostium was detected.An unknown (non-bsc) stent was overlapped with a bsc stent in the ostial lad.Stenting was attempted in the ostial ramus to overlap with the recently placed stent.Full sds balloon expansion could not be achieved during the ostial stent deployment due to heavy calcification in an area just proximal to the previously placed stent.It is possible that this arterial segment was never adequately dilated.The sds balloon became stuck in the stent and per the complaint report obstructed blood flow after it sheared from the delivery catheter.The patient was rushed to open heart surgery but ultimately did not survive.The review concluded with the following: the images provided are consistent with fatal difficulty removing stent delivery system balloon requiring additional surgical intervention as alleged in the complaint.Interaction between the stent, the delivery system and the calcified vessel likely contributed to the difficulty withdrawing the sds and subsequent device separation.Device separation causing vessel obstruction and consequent myocardial ischemia led to emergency open heart surgery.Advanced coronary artery disease, prolonged ischemia and surgical complications likely contributed to the fatal heart failure outcome.Difficulty withdrawing the device (stuck in lesion), device separation leading to vessel obstruction, myocardial ischemia and death are included in the promus elite risk management documentation.
 
Event Description
It was reported that a patient death occurred.A percutaneous transluminal coronary angioplasty (ptca) was performed on a radius intermedius and left anterior descending target lesion for a patient for acute myocardial infarction.A 8 x 2.50 promus elite mr stent was successfully deployed in the radius intermedius.A 16 x 2.50 promus elite mr stent was then deployed in the radius intermedius.Removal difficulties were encountered during withdrawal attempts of the deflated stent delivery balloon.A 12 x 2.75 promus elite mr stent and an 8 x 3.00 promus elite mr stent were deployed in the left anterior descending artery (lad) with success.Angiography was performed in a different coronary plane.Another lesion was observed in the ramus intermedius.A 16 x 2.50 promus elite mr stent was deployed in the ramus intermedius lesion, proximal to the first two drug eluting stents (2.5 x 8mm promus elite stent and 16 x 2.50 mm promus elite stent).The 16 x 2.50 promus elite mr was deployed at 14 atmospheres overlapping one of the previously placed promus elite stents.The angiography indicated that at one place or location the stent was not fully inflated.The 16 x 2.50 promus elite mr stent delivery balloon was deflated and inflated up to 14 atmospheres several times.Due to the vessel size, it was not possible to apply a higher pressure.The 16 x 2.50 promus elite mr stent was still not fully inflated.A non-compliant (nc) balloon was used in attempt to withdraw the 6 x 2.50 promus elite mr delivery balloon and to post dilate the 6 x 2.50 promus elite mr.It was not possible to mobilize the stent delivery balloon despite using the non-compliant (nc) balloon.The balloon on the 6 x 2.50 promus elite mr tore off the catheter.Subsequently, there was no blood flow into the vessel.The patient experienced angina pectoris and ecg changes were noticed.The patient was intubated for transportation.The patient had to be transferred for an emergency coronary artery bypass surgery.Following bypass surgery, the patient passed away due to heart failure on the intensive care unit.
 
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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
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key14287987
MDR Text Key290780210
Report Number2134265-2022-05205
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 06/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/05/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date11/15/2023
Device Model Number10672
Device Catalogue Number10672
Device Lot Number0028417351
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/16/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/15/2021
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Death;
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