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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM; SELF EXPANDING PERIPHERAL STENT SYSTEM
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ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM; SELF EXPANDING PERIPHERAL STENT SYSTEM Back to Search Results
Model Number 1012535-100
Medical Device Problem Code Premature Activation (1484)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 10/27/2021
Type of Reportable Event Malfunction
Additional 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 from this lot.It is possible that during unpackaging/removal of the stylet, the tip was inadvertently pulled causing the stent to slightly be exposed; however this cannot be confirmed.The investigation determined a conclusive cause for the reported difficulties cannot be determined.There is no indication of a product quality issue with respect to design, manufacture or labeling.
 
Event or Problem Description
It was reported after unpacking a 7x100mm absolute pro self-expanding stent system (sess), the stent was noted to be exposed and not flowered.The device was not used and there was no patient involvement.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
 
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Brand Name
ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM
Common Device Name
SELF EXPANDING PERIPHERAL STENT SYSTEM
MDR Report Key12748940
Report Number2024168-2021-09965
Device Sequence Number14494612
Product Code NIP
UDI-Device Identifier08717648176098
UDI-Public08717648176098
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
P110028
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 11/03/2021
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
Operator of Device Health Professional
Device Expiration Date04/30/2024
Device Model Number1012535-100
Device Catalogue Number1012535-100
Device Lot Number1052661
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 10/27/2021
Initial Report FDA Received Date11/03/2021
Was Device Evaluated by Manufacturer? (Y/N) Device Not Returned to Manufacturer
Date Device Manufactured05/26/2021
Is the Device Labeled for Single Use? (Y/N) Yes
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Initial
Patient Sequence Number1
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