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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AV-TEMECULA-CT OMNILINK ELITE PERIPHERAL STENT DELIVERY SYSTEM; PERIPHERAL STENT SYSTEM

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AV-TEMECULA-CT OMNILINK ELITE PERIPHERAL STENT DELIVERY SYSTEM; PERIPHERAL STENT SYSTEM Back to Search Results
Catalog Number 11003-59
Device Problems Device Damaged by Another Device (2915); Material Deformation (2976)
Patient Problem Thrombosis (2100)
Event Date 08/16/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4).Medical devices: 6 f terumo introducer sheath, omnilink elite 9mm stent delivery system.The stent remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The other omnilink elite device is filed under a separate manufacturing report number.
 
Event Description
It was reported that, via a 6 f terumo introducer sheath, an omnilink elite 7mm stent was successfully implanted in the external iliac artery, heavily calcified lesion.An omnilink elite 9mm stent delivery system (sds), for intended implant in the internal iliac artery, was advanced into the 6f terumo introducer sheath with significant resistance.Once the omnilink 9mm sds was at the previously implanted 7mm stent, the 9mm stent dislodged.The delivery catheter balloon tip was still at the distal end of the dislodged stent.The balloon was partially inflated to retrieve the stent; however, during withdrawal, the 9mm stent caught the proximal portion of the implanted omnilink 7mm stent.The omnilink 7mm stent elongated.The omnilink 9mm sds with stent and terumo sheath were removed as a single unit.A new introducer sheath was inserted.A 7mm balloon was used to dilatate the implanted omnilink 7mm stent with acceptable results.The internal iliac lesion was left without further treatment.Endarterectomy was performed within the femoral vessel.The following day, on (b)(6) 2017, the external iliac artery occluded with thrombus.On (b)(6) 2017, another endarterectomy was performed in addition to "patch-plastic" of the femoral vessel.Another percutaneous intervention was performed, placing a non-abbott stent in the distal stent, and thrombectomy and stent implant was performed within the iliac vessels distal to the 7mm omnilink stent.Reportedly, the patient is in good condition.There was no additional information provided regarding this issue.
 
Manufacturer Narrative
(b)(4).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 of the reported lot revealed no other incidents.It should be noted that the reported patient effect of stent thrombosis is listed in the omnilink elite peripheral stent system instructions for use (ifu) as a known potential adverse event.The investigation determined that the reported difficulties and subsequent patient effects are related to circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
 
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Brand Name
OMNILINK ELITE PERIPHERAL STENT DELIVERY SYSTEM
Type of Device
PERIPHERAL STENT SYSTEM
Manufacturer (Section D)
AV-TEMECULA-CT
abbott vascular
26531 ynez road
temecula CA 92591 4628
Manufacturer (Section G)
CLONMEL, IRELAND REG# 9616693
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 Key6856388
MDR Text Key85735616
Report Number2024168-2017-07391
Device Sequence Number1
Product Code NIO
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
P110043
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Health Professional
Remedial Action Other
Type of Report Initial,Followup
Report Date 11/09/2017
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? Yes
Device Operator Health Professional
Device Expiration Date09/30/2020
Device Catalogue Number11003-59
Device Lot Number7041041
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/17/2017
Initial Date FDA Received09/11/2017
Supplement Dates Manufacturer Received11/01/2017
Supplement Dates FDA Received11/09/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/01/2017
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;
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