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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AV-TEMECULA-CT ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM; SELF EXPANDING STENT SYSTEM

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AV-TEMECULA-CT ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM; SELF EXPANDING STENT SYSTEM Back to Search Results
Catalog Number 1012538-60
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hematoma (1884); Pain (1994); Rash (2033); Swelling (2091)
Event Date 09/01/2013
Event Type  Injury  
Event Description
It was reported that the patient has leg pain that is worse now than it was prior to the stenting procedure in (b)(6) 2013.In (b)(6) 2013, an absolute pro stent was implanted in the left iliac artery.That night, or the following day, the patient had itching, hives, increased leg pain, pulsating/throbbing leg pain.The generalized itching and hives lasted about three to four months, but the leg pain is continuing.The left leg is tender to touch.Her physicians are aware of the patient condition, but the patient was told this is normal and that she has neuropathy.No further diagnostics nor treatment have been performed.Her ankle is swollen and her leg just doesn't feel right.The leg has bruising and broken veins.She had broken veins previously but it was not this bad.Reportedly, she cannot eat shell fish because it makes her itchy with hives, but she did not tell the vascular surgeon about this prior to her stenting procedure.The vascular surgeon told her that the iliac lesion was ballooned ten to eleven times during the procedure.There was no additional information provided.
 
Manufacturer Narrative
Date of event, implant date: estimated dates (reported as (b)(6) 2013).There was no reported device malfunction, and the product was not returned.The reported patient effect of pain is a known observed and potential patient effect as listed in the absolute pro instruction for use.Although 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 deficiency with respect to manufacturing, design or labeling.
 
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Brand Name
ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM
Type of Device
SELF EXPANDING STENT SYSTEM
Manufacturer (Section D)
AV-TEMECULA-CT
abbott vascular
26531 ynez road
temecula CA 92591 462
Manufacturer (Section G)
ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168
abbott vascular
26531 ynez road
temecula CA 92591 462
Manufacturer Contact
connie speck
abbott vascular
26531 ynez road
temecula, CA 92591-4628
9519143996
MDR Report Key3933037
MDR Text Key18728395
Report Number2024168-2014-04509
Device Sequence Number1
Product Code NIO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P110028
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Patient
Remedial Action Other
Type of Report Initial
Report Date 07/10/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number1012538-60
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 07/10/2014
Initial Date FDA Received07/14/2014
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 Sequence Number1
Patient Outcome(s) Other;
Patient Age54 YR
Patient Weight86
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