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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PROMUS ELEMENT; STENT, CORONARY, DRUG-ELUTING
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BOSTON SCIENTIFIC CORPORATION PROMUS ELEMENT; STENT, CORONARY, DRUG-ELUTING Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hypersensitivity/Allergic reaction (1907)
Event Date 11/01/2018
Event Type  Injury  
Manufacturer Narrative
Device is a combination product.Date of event: unknown.Used the first date of the month of the aware date.
 
Event Description
It was reported that the patient experienced allergic reaction.In (b)(6) 2014, a promus element drug eluting stent (des) was used for treatment.After eight weeks, fever and respiratory problem occurred.It was reported that drug-induced lung injury occurred which was considered to be caused by everolimus contained in promus des.Investigation was performed on des-derived drug-induced lung injury reported in the past.There were also reports of drug-induced lung injury not only on promus but also for taxus stent in the past.Taxus stents contains paclitaxel, but when paclitaxel was systemically administered as an anticancer agent for lung cancer.Paclitaxel was used as a solvent dissolved in cremophor el (castor oil).Among the drug-induced lung injuries caused by systemic administration of paclitaxel, it was considered that was due to the allergic reaction which was caused by the castor oil.Steroid therapy was effective and the patient's progress is good.No change of dual antiplatelet therapy currently.
 
Event Description
It was reported that the patient experienced allergic reaction.In (b)(6) 2014, a promus element drug eluting stent (des) was used for treatment.After eight weeks, fever and respiratory problem occurred.It was reported that drug-induced lung injury occurred which was considered to be caused by everolimus contained in promus des.It was further reported that two promus element stents were implanted, a 2.75x28mm and a 3.0x24mm.Steroid therapy was effective and the patient progress was good.There was no change in dual antiplatelet therapy.
 
Manufacturer Narrative
Device is a combination product.Date of event: unknown.Used the first date of the month approximately 8 weeks from implant date.
 
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Brand Name
PROMUS ELEMENT
Type of Device
STENT, CORONARY, DRUG-ELUTING
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key8141460
MDR Text Key129587224
Report Number2134265-2018-63429
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,distri
Type of Report Initial,Followup
Report Date 12/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/07/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received11/12/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
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