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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PROMUS PREMIER; STENT, CORONARY, DRUG-ELUTING
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BOSTON SCIENTIFIC CORPORATION PROMUS PREMIER; STENT, CORONARY, DRUG-ELUTING Back to Search Results
Model Number 9550
Device Problems Fracture (1260); Activation Failure (3270)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/07/2021
Event Type  Injury  
Manufacturer Narrative
Initial reporter name and address: (b)(6).
 
Event Description
It was reported that insufficient apposition and stent fracture occurred.The 80% stenosed target lesion with a 4.2mm proximal and 2.75mm distal external elastic membrane (eem) vessel diameter was located in the non-tortuous and non-calcified left anterior descending (lad) artery.Patient was previously treated for acute anterior wall myocardial infarction and underwent thrombolysis and percutaneous transluminal coronary angioplasty (ptca).Further treatment was needed for tip aneurysm formation.Coronary artery angiography showed lesion in the left anterior descending (lad) artery and the optical coherence tomography (oct) examination showed local thrombus accumulation in the middle segment of the lad.The intima of the vessel wall was torn and local dissection was formed.A 20 x 3.00 promus premier drug-eluting stent was implanted in the middle segment of the anterior descending branch.However, the angiography indicated that the stent was not well attached, so the stent was dilated with a 4.0 x 12 mm non-boston scientific balloon at 12 atmospheres for 6 seconds.Repeated oct examination indicated that the proximal segment of the stent could be attached on the wall, while local steel beam fracture was found in the middle segment, and the distal segment of the stent was not attached well.After withdrawal of the oct examination catheter, repeated angiography indicated that the proximal segment of the anterior descending branch of the stent was fractured and displaced.It was noted the cause possibly being due to the retraction of the oct catheter, hanging the distal stent, pulling the distal stent to the proximal end and the stent overlapped.The stent overlap could be seen on angiography and the length of the stent also appeared shortened.No further treatment was performed and the procedure was terminated with timi 3 blood flow level.Double antiplatelet and lipid-regulating therapy were continued.Cardiac surgery was recommended to treat coronary artery disease.The device was retained near the anterior descending branch.There were no patient complications reported and the patient was stable post procedure.
 
Manufacturer Narrative
E1 - initial reporter facility name: (b)(6).Device evaluated by mfr: promus premier ous mr 20 x 3.00 mm stent delivery system was returned for analysis.The device was returned without the stent.A review of the manufacturing stent profile data was performed and the stent outer diameter at the time of manufacture was within max crimped stent profile measurement.The balloon cones were reviewed, and signs of positive pressure were noted as its wings were unfolded and crimp markings could be noted on the balloon folds.An examination (visual and via scope) found no evidence of tip damage.A visual and tactile examination of the hypotube shaft found multiple kinks along the length of the hypotube shaft.A visual examination of the outer and inner lumen and mid-shaft section found no issues.After soaking the device in an overnight water bath, a verified inflation device was used to inflate the device.The device held pressure at 16 atm for one minute and deflated within 9 seconds.No other issues were identified during the product analysis.
 
Event Description
It was reported that insufficient apposition and stent fracture occurred.The 80% stenosed target lesion with a 4.2mm proximal and 2.75mm distal external elastic membrane (eem) vessel diameter was located in the non-tortuous and non-calcified left anterior descending (lad) artery.Patient was previously treated for acute anterior wall myocardial infarction and underwent thrombolysis and percutaneous transluminal coronary angioplasty (ptca).Further treatment was needed for tip aneurysm formation.Coronary artery angiography showed lesion in the left anterior descending (lad) artery and the optical coherence tomography (oct) examination showed local thrombus accumulation in the middle segment of the lad.The intima of the vessel wall was torn and local dissection was formed.A 20 x 3.00 promus premier drug-eluting stent was implanted in the middle segment of the anterior descending branch.However, the angiography indicated that the stent was not well attached, so the stent was dilated with a 4.0 x 12 mm non-boston scientific balloon at 12 atmospheres for 6 seconds.Repeated oct examination indicated that the proximal segment of the stent could be attached on the wall, while local steel beam fracture was found in the middle segment, and the distal segment of the stent was not attached well.After withdrawal of the oct examination catheter, repeated angiography indicated that the proximal segment of the anterior descending branch of the stent was fractured and displaced.It was noted the cause possibly being due to the retraction of the oct catheter, hanging the distal stent, pulling the distal stent to the proximal end and the stent overlapped.The stent overlap could be seen on angiography and the length of the stent also appeared shortened.No further treatment was performed and the procedure was terminated with timi 3 blood flow level.Double antiplatelet and lipid-regulating therapy were continued.Cardiac surgery was recommended to treat coronary artery disease.The device was retained near the anterior descending branch.There were no patient complications reported and the patient was stable post procedure.
 
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Brand Name
PROMUS PREMIER
Type of Device
STENT, CORONARY, DRUG-ELUTING
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key12243113
MDR Text Key264052309
Report Number2134265-2021-09424
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 09/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/28/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/15/2023
Device Model Number9550
Device Catalogue Number9550
Device Lot Number0027014649
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/27/2021
Date Manufacturer Received08/24/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
Patient Age36 YR
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