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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE PROA EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

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ABBOTT VASCULAR XIENCE PROA EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT DELIVERY SYSTEM Back to Search Results
Catalog Number 1128250-18
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hypersensitivity/Allergic reaction (1907)
Event Date 12/25/2019
Event Type  Injury  
Event Description
It was reported that the procedure was to treat an acute myocardial infarction in an unspecified artery. The 2. 5x18mm xience proa stent was successfully implanted in 2019, however, the patient fears that she developed an allergic reaction to the material components. The patient already had existing symptoms of me/cfs (myalgic encephalomyelitis/chronic fatigue syndrome) with severe fatigue, pain and neurological symptoms. Despite all the therapies the symptoms worsened significantly after the stent was implanted. It is known that due to a detoxification disorder, high metal levels in the blood were sometimes detectable. There are significant intolerances to various drugs. Recently, frequent extrasystoles and pain have occurred, the cause of which has not really been clarified so far. The patient was in the past allergy tested, but not on the xience stent components and it is well known that the patient has an intolerances to various drugs. No treatment has been provided currently as the physician is unclear if there is a connection between the stent material and the symptoms of the patient. The allergic reaction has not been resolved. No additional information was provided.
 
Manufacturer Narrative
The device was not returned for analysis. A review of the lot history record and complaint history of the reported lot could not be conducted because the lot number was not provided. The reported patient effect of hypersensitivity is listed in the xience alpine/proa everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary stenting procedures. A conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined. There is no indication of a product quality issue with respect to manufacture, design, or labeling. The xience proa device is currently not commercially available in the us; however, it is similar to a device sold in the us. The udi is unknown because the part/lot number were not provided.
 
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Brand NameXIENCE PROA EVEROLIMUS ELUTING CORONARY STENT SYSTEM
Type of DeviceDRUG ELUTING CORONARY STENT DELIVERY SYSTEM
Manufacturer (Section D)
ABBOTT VASCULAR
26531 ynez rd.
temecula CA 92591 4628
Manufacturer (Section G)
ABBOTT VASCULAR, REG # 3005718570 (P031)
cashel road
clonmel tipperary
EI
Manufacturer Contact
lindsey bell
26531 ynez rd.
temecula, CA 92591-4628
9519143996
MDR Report Key14880999
MDR Text Key295107880
Report Number2024168-2022-07105
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeGM
PMA/PMN Number
P110019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation
Type of Report Initial
Report Date 06/30/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/30/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number1128250-18
Was Device Available for Evaluation? No
Date Manufacturer Received06/10/2022
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: 06/30/2022 Patient Sequence Number: 1
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