MAUDE Adverse Event Report: ABBOTT VASCULAR INC. ABSOLUTE PRO; STENT, ILIAC

Model Number	1012531-100
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Difficult or Delayed Activation (2577); Malposition of Device (2616); Deformation Due to Compressive Stress (2889); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure performed was to treat a de novo, 70% stenosed, moderately calcified common iliac artery.The 9.0x100mm absolute pro self-expanding stent system (sess) was advanced; however, during deployment the thumbwheel became stuck and the stent only partially deployed.The handle was dismantled in an attempt to manually deploy the ses; however, this was unsuccessful.Multiple attempts were made to remove the sess, but resistance was met with the sharp bifurcation and the sheath.During the removal attempts the shaft kinked and separated half outside the body.Forceps were used to remove the shaft.The sheath was pulled back into the aorta and the stent ultimately deployed, partially in an unintended location of the aorta and partially in the intended area covering the lesion to the physician's satisfaction.There were no adverse patient sequelae and no clinically significant delay in procedure.Further review of the part and lot number found that the absolute pro sess was used after expiration.No additional information was provided.
Additional Manufacturer Narrative
The device was returned for analysis.The reported physical resistance / sticking, difficult or delayed activation, and difficult to remove were unable to be replicated in a testing environment due to returned device condition (stent previously deployed).The reported material separation and deformation due to compressive stress were able to be confirmed.The reported malposition of device and difficult to remove from the anatomy were unable to be replicated in a testing environment as it was based on operational circumstances.Production record and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint handling database identified no other incidents from this lot.Reportedly, the absolute pro self-expanding stent (ses) was implanted and it was then noted that the device is expired.It should be noted that the absolute pro.035 peripheral self-expanding stent system instructions for use (ifu) states: "use prior to the ¿use by¿ date specified on the package".As there was no damage noted to the device during the inspection prior to use, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that interaction with the moderately calcified, 70% stenosed anatomy with sharp bifurcation resulted in preventing the shaft lumens from moving freely; thus resulting in the reported physical resistance thumbwheel and partial difficult or delayed activation.Further interaction with the sharp bifurcation in attempts to remove the device resulted in the reported difficult to remove.Manipulation of the compromised device resulted in the reported/noted shaft kink, the reported/noted material separation, and the noted device damages (separated tip with the inner member, multiple inner member kinks/splits kinked jacket).Interaction of the compromised device with the introducer sheath resulted in the reported difficult to remove.Further attempt to remove the device resulted in the introducer sheath being pulled back into the aorta, resulting in the ses ultimately deploying partially in an unintended location and partially in the intended area per the physician's satisfaction.There is no indication of a product quality issue with respect to manufacture, design or labeling.H6 medical device problem code: 2017 - use after expiration.

• Brand Name: ABSOLUTE PRO
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 2807
• 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 Key: 24405925
• Report Number: 2024168-2026-00723
• Device Sequence Number: 12817897
• Product Code: NIO
• UDI-Device Identifier: 08717648175817
• UDI-Public: (01)08717648175817(17)251031(10)2110361
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P110028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/20/2026

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2025
• Device Model Number: 1012531-100
• Device Catalogue Number: 1012531-100
• Device Lot Number: 2110361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/03/2022
• 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 Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 81 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White