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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 11011-29
Device Problems Patient-Device Incompatibility (2682); Difficult to Advance (2920); Migration (4003)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/08/2022
Event Type  Injury  
Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
 
Event Description
It was reported that the procedure was to treat the mildly calcified, moderately tortuous, 90% stenosed subclavian artery.The 8x29 mm omnilink elite stent delivery system (sds) was advanced to the lesion and the stent was implanted.However, due to poor wall apposition, the stent migrated to the proximal subclavian artery yet still a portion was in the target lesion.An 8x39 mm omnilink elite sds was attempted to be implanted to engage the other stent but it would not engage so the 8x39 mm omnilink sds was removed.There were no reported adverse patient sequela and there was no clinically significant delay in the procedure.No additional information was provided.
 
Manufacturer Narrative
The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no other incidents.The investigation determined the reported difficulties and subsequent treatment appears to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design, or labeling.D4: part/lot numbers, expiration date d9/h3: device availability h4: manufacturing date.
 
Event Description
It was reported that the procedure was to treat the mildly calcified, moderately tortuous, 90% stenosed subclavian artery.The 8x29 mm omnilink elite stent delivery system (sds) was advanced to the lesion and the stent was implanted.However, due to poor wall apposition, the stent migrated to the proximal subclavian artery yet still a portion was in the target lesion.An 8x39 mm omnilink elite sds was attempted to be implanted to engage the other stent but it would not engage so the 8x39 mm omnilink sds was removed.There were no reported adverse patient sequela and there was no clinically significant delay in the procedure.Subsequent to the initially filed report, the following information was provided: the 8x39 mm omnilink elite sds could not cross the previously implanted stent.There were no other device issues.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 Key13940769
MDR Text Key288127297
Report Number2024168-2022-03281
Device Sequence Number1
Product Code NIO
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
P110043
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 05/09/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/29/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number11011-29
Device Lot Number1081741
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/20/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/17/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
8X39 MM OMNILINK ELITE SDS
Patient Outcome(s) Required Intervention;
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