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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 UNK XIENCE PROA
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Angina (1710); Headache (1880); Hypersensitivity/Allergic reaction (1907); High Blood Pressure/ Hypertension (1908); Pain (1994)
Event Date 02/07/2022
Event Type  Injury  
Manufacturer Narrative
Date of event: estimated. The unique device identifier (udi) is unknown because the part number and lot number were not provided. Date of implant: estimated. The device was not returned for analysis. A review of the electronic lot history record (elhr) for this product was not performed because the part and lot numbers were not reported and the product was not returned for analysis. The reported patient effects of hypertension, angina, pain and hypersensitivity are listed in the xience pro a everolimus eluting coronary stent systems instructions for use (ifu) as known patient effects of coronary stenting procedures. A conclusive cause for the reported patient effects, 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.
 
Event Description
It was reported that in 2018, a xience pro a stent, and a non-abbott stent were implanted. Months after the implantation of the stents, the patient developed hypertension, headache, chest pain, pain in the shoulder joint and pain in the cervical spine. The patient¿s cardiologist assumed that the symptoms could be triggered by a metal allergy. No additional information was 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 (P099)
cashel road
clonmel tipperary
EI
Manufacturer Contact
lindsey bell
26531 ynez rd.
temecula, CA 92591-4628
9519143996
MDR Report Key13588959
MDR Text Key286642890
Report Number2024168-2022-01957
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 Foreign,Consumer,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 02/23/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/23/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK XIENCE PROA
Was Device Available for Evaluation? No
Date Manufacturer Received02/07/2022
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: 02/23/2022 Patient Sequence Number: 1
Treatment
BOSTON SCIENTIFIC SYNERGY STENT
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