Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR ABSOLUTE PRO LL SELF-EXPANDING STENT SYSTEM; SELF EXPANDING PERIPHERAL STENT SYSTEM
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ABBOTT VASCULAR ABSOLUTE PRO LL SELF-EXPANDING STENT SYSTEM; SELF EXPANDING PERIPHERAL STENT SYSTEM Back to Search Results
Catalog Number 1013015-120
Device Problems Break (1069); Difficult or Delayed Activation (2577); Noise, Audible (3273); Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/16/2021
Event Type  Injury  
Event Description
It was reported that the procedure was to treat a 90% stenosed, mildly calcified and mildly tortuous vessel in the superficial femoral artery (sfa).The 5.0x120mm absolute pro self-expanding stent system (sess) was advanced to the target lesion.However, upon deployment there was resistance when rolling back the thumbwheel and the stent partially deployed.While continuing to rotate the thumbwheel, the sess made an abnormal sound and the unreleased stent portion was found to be broken.However, the stent was completely deployed in the vessel.The physician withdrew the sess without the stent since it was implanted.Another same size absolute pro was used to cover the broken stent.There was no adverse patient sequela and there was no clinically significant delay in the procedure.No additional information was provided.
 
Manufacturer Narrative
The device is expected to be returned for evaluation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
 
Manufacturer Narrative
The device is expected to be returned for evaluation.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 a 90% stenosed, mildly calcified and mildly tortuous vessel in the superficial femoral artery (sfa).The 5.0x120mm absolute pro self-expanding stent system (sess) was advanced to the target lesion.However, upon deployment there was resistance when rolling back the thumbwheel and the stent partially deployed.While continuing to rotate the thumbwheel, the sess made an abnormal sound and the unreleased stent portion was found to be broken.However, the stent was completely deployed in the vessel.The physician withdrew the sess without the stent since it was implanted.Another same size absolute pro was used to cover the broken stent.There was no 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 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 similar complaints reported from this lot.The investigation was unable to determine a cause for the reported difficulties resulting in unexpected medical intervention.It may be possible that the distal shaft was bent or restricted within the anatomy (possibly at the aortic bifurcation) preventing the shaft lumens from moving freely and causing resistance with the thumbwheel.Continued force applied in the attempt to rotate the thumbwheel may have placed excessive tension on the ribbon which may have caused the outer member to separate at the shuttle resulting in the abnormal sound and preventing further deployment.However, without having the device to examine, 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: return status updated.
 
Event Description
It was reported that the procedure was to treat a 90% stenosed, mildly calcified and mildly tortuous vessel in the superficial femoral artery (sfa).The 5.0x120mm absolute pro self-expanding stent system (sess) was advanced to the target lesion.However, upon deployment there was resistance when rolling back the thumbwheel and the stent partially deployed.While continuing to rotate the thumbwheel, the sess made an abnormal sound and the unreleased stent portion was found to be broken.However, the stent was completely deployed in the vessel.The physician withdrew the sess without the stent since it was implanted.Another same size absolute pro was used to complete the procedure.There was no adverse patient effect and there was no clinically significant delay in the procedure.Subsequent to the initially filed report, the following information was provided: the second absolute pro stent was used to cover the broken stent.No additional information was provided.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ABSOLUTE PRO LL SELF-EXPANDING STENT SYSTEM
Type of Device
SELF EXPANDING PERIPHERAL STENT SYSTEM
Manufacturer (Section D)
ABBOTT VASCULAR
26531 ynez rd.
temecula CA 92591 4628
Manufacturer (Section G)
ABBOTT VASCULAR, REG # 2024168
26531 ynez road
temecula CA 92591 4628
Manufacturer Contact
lindsey bell
26531 ynez rd.
temecula, CA 92591-4628
9519143996
MDR Report Key13177851
MDR Text Key286235656
Report Number2024168-2022-00176
Device Sequence Number1
Product Code NIP
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
P110028
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 02/24/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/06/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/31/2023
Device Catalogue Number1013015-120
Device Lot Number0021761
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/14/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/17/2020
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) Required Intervention;
-
-