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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 1012531-60
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hypersensitivity/Allergic reaction (1907); Swelling (2091)
Event Date 08/06/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4).The device was not returned for evaluation.A review of the lot history record revealed no exceptions associated with this lot.It should be noted that the reported patient effect of allergic reaction is listed in the absolute pro instruction for use (ifu) as a known patient effect.Based on the case information and related record review, a conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined.The treatment with medications and hospitalization are due to case circumstances.There is no indication of a product quality issue.The other absolute pro device is filed under a separate medwatch report number.
 
Event Description
It was reported that on (b)(6) 2018, two absolute pro stents were implanted without reported issue in the patient's groin area.Since implantation, the patient has been itching and has a swollen face.The patient has not experienced any difficulty breathing.The patient was hospitalized twice for the allergic reaction and medication benadryl and steroids were provided.No additional information was provided regarding this issue.
 
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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 4628
Manufacturer (Section G)
ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168
abbott vascular
26531 ynez road
temecula CA 92591 4628
Manufacturer Contact
connie speck
abbott vascular
26531 ynez road
temecula, CA 92591-4628
9519143996
MDR Report Key7936313
MDR Text Key122796446
Report Number2024168-2018-07689
Device Sequence Number1
Product Code NIO
UDI-Device Identifier08717648175794
UDI-Public08717648175794
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 Non-Healthcare Professional
Remedial Action Other
Type of Report Initial
Report Date 10/04/2018
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 Expiration Date08/31/2019
Device Catalogue Number1012531-60
Device Lot Number6090162
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 09/17/2018
Initial Date FDA Received10/04/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/01/2016
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) Hospitalization; Required Intervention;
Patient Age76 YR
Patient Weight61
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