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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR RX HERCULINK ELITE STENT SYSTEM; STENT, RENAL
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ABBOTT VASCULAR RX HERCULINK ELITE STENT SYSTEM; STENT, RENAL Back to Search Results
Model Number 1011505-15
Device Problems Break (1069); Leak/Splash (1354); Off-Label Use (1494)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/13/2021
Event Type  malfunction  
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 an unspecified lesion.A 7x15mm herculink was advanced to the lesion and inflated once at 4 atmospheres, when leakage was noted coming from the hub due to a crack.An unspecified balloon was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
 
Manufacturer Narrative
The device was not returned for evaluation.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 complaints reported from this lot.Because it was reported that the herculink elite was being used to treat a subclavian artery, it should be noted that the indication section of the herculink elite instruction for use (ifu) states: the rx herculink elite renal stent system is indicated for use in patients with atherosclerotic disease of the renal arteries following sub-optimal percutaneous transluminal renal angioplasty (ptra) of a de novoor restenotic atherosclerotic lesion(= 15 mm in length) located within 10 mm of the renal ostium and with a reference vessel diameter of 4.0 ¿ 7.0 mm.Suboptimal ptra is defined as = 50% residual stenosis, = 20 mmhg peak systolic or = 10 mmhg mean translesional pressure gradient, flow -limiting dissection, or timi [thrombolysis in myocardial infarction] flow < 3.In this case, the off-label use does not appear to have contributed to the reported difficulties.Based on the information provided, a definitive cause for the reported leak and hub crack could not be determined.It may be possible that the rotator on the inflation device was over-tightened onto the treads causing the hub to crack and resulting in leak; however, this could not be confirmed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.D9, h3 - device status changed from returning to discarded.
 
Event Description
It was reported that the procedure was to treat an unspecified lesion.A 7x15mm herculink was advanced to the lesion and inflated once at 4 atmospheres, when leakage was noted coming from the hub due to a crack.An unspecified balloon was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.Subsequent to the initially filed mdr, it was confirmed that the procedure was to treat a subclavian artery stenosis.No additional information was provided.
 
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Brand Name
RX HERCULINK ELITE STENT SYSTEM
Type of Device
STENT, RENAL
Manufacturer (Section D)
ABBOTT VASCULAR
26531 ynez rd.
temecula CA 92591 4628
MDR Report Key11729147
MDR Text Key248840556
Report Number2024168-2021-03544
Device Sequence Number1
Product Code NIN
UDI-Device Identifier08717648078378
UDI-Public08717648078378
Combination Product (y/n)N
PMA/PMN Number
P110001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 06/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/26/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/31/2022
Device Model Number1011505-15
Device Catalogue Number1011505-15
Device Lot Number9081561
Was Device Available for Evaluation? No
Date Manufacturer Received06/04/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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