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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR OMNILINK ELITE PERIPHERAL STENT SYSTEM; PERIPHERAL STENT DELIVERY SYSTEM

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ABBOTT VASCULAR OMNILINK ELITE PERIPHERAL STENT SYSTEM; PERIPHERAL STENT DELIVERY SYSTEM Back to Search Results
Catalog Number 11011-39
Device Problem Stretched (1601)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/20/2023
Event Type  malfunction  
Manufacturer Narrative
The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents.The investigation was unable to determine a conclusive cause for the reported stretched stent.There is no indication of a product quality issue with respect to manufacture, design, or labeling na.
 
Event Description
It was reported that the procedure was to treat a moderately calcified iliac artery that is 70% stenosed.The 8.0x39mm omnilink elite 35 stent was deployed; however, it was noted that the stent length had elongated to 61mm.There was no adverse patient effects reported and no clinically significant delay reported.No additional information was provided.
 
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Brand Name
OMNILINK ELITE PERIPHERAL STENT SYSTEM
Type of Device
PERIPHERAL 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 Key17552534
MDR Text Key321644299
Report Number2024168-2023-08825
Device Sequence Number1
Product Code NIO
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
P110043
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 08/15/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number11011-39
Device Lot Number2081541
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/21/2023
Initial Date FDA Received08/15/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/15/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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