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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM STENT, CORONARY, DRUG-ELUTING

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BOSTON SCIENTIFIC - GALWAY PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM STENT, CORONARY, DRUG-ELUTING Back to Search Results
Model Number UNK717
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Congestive Heart Failure (1783); Death (1802); Dyspnea (1816); Edema (1820); Myocardial Infarction (1969)
Event Date 01/04/2018
Event Type  Death  
Manufacturer Narrative
Device is a combination product. Device evaluated by mfr. : the device was not returned for analysis. The investigation conclusion was unable to be determined. (b)(4).
 
Event Description
Same case as mdr id 2134265-2018-04060 and 2134265-2018-04061. (b)(6) clinical study. It was reported that non-st elevation myocardial infarction (nstem) and death occurred. In (b)(6) 2013, the patient presented due to unstable angina and myocardial infarction. Subsequently, angiography and the index procedure were performed. Target lesion #1 was located in the proximal segment (ostial lesion) of saphenous vein graft (svg) to right posterior descending artery (rpda) with 80% in-stent restenosis (isr) of a previously deployed unknown drug-eluting stent (des) and was 35 mm long with a reference vessel diameter of 3. 5 mm. Target lesion #1 was treated with pre-dilatation and placement of a 3. 50 x 38 mm promus element plus drug-eluting stent. Following post dilatation, residual stenosis was 0%. Target lesion #2 was a de novo lesion located in the mid segment of svg to rpda with 70% isr of a previously deployed unknown des and was 35 mm long with a reference vessel diameter of 3. 0 mm. Target lesion #2 was treated with direct stent placement using a 3. 00 x 38 mm promus element plus drug-eluting stent. Following post dilatation, residual stenosis was 0%. Target lesion #3 was a de novo lesion located in the distal segment of svg to rpda with 90% stenosis and was 6 mm long with a reference vessel diameter of 3. 0 mm. Target lesion #3 was treated with direct stent placement using a 3. 00 x 8 mm promus element plus drug-eluting stent. Following post dilatation, residual stenosis was 0%. On the following day, the patient was discharged on aspirin and clopidogrel. In (b)(6) 2018, the patient presented with complaints of lower extremity edema and shortness of breath. An elevation in cardiac enzyme was noted. The patient was diagnosed with nstemi and referred to the hospital for further evaluation. The patient had code status of do not resuscitate (dnr) and as the patient had a risk of renal failure (esrd secondary to lupus nephritis status post renal transplant) coronary angiogram was deferred. It was decided to treat the nstemi medically and to provide comfort care to the patient. During the hospitalization the patient had atrial fibrillation which was treated with medications, severe metabolic acidosis which was treated with electrolyte replacement and anemia with hemoglobin. No medications were given in response to nstemi. Eleven days after, the event nstemi was considered to be resolved. On the same day the patient was discharged from the hospital and was transferred to the transitional care unit (tcu) for continued rehab with palliative care. In (b)(6) 2018 while in tcu the patient's health started to decline due to worsening heart failure and the patient was placed on hospice care. It was reported that the patient was brought home and on the next day, the patient was found expired at home. The patient expired due to worsening heart failure. The cause of death was congestive heart failure.
 
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Brand NamePROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
Type of DeviceSTENT, CORONARY, DRUG-ELUTING
Manufacturer (Section D)
BOSTON SCIENTIFIC - GALWAY
Manufacturer (Section G)
BOSTON SCIENTIFIC - GALWAY
Manufacturer Contact
sonali arangil
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key7500138
MDR Text Key107779084
Report Number2134265-2018-04062
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P110010
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 04/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/09/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberUNK717
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/16/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/09/2018 Patient Sequence Number: 1
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