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

Model Number	1012535-100
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Difficult or Delayed Activation (2577); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the distal superficial femoral artery with heavy calcification.The 7.0x100mm absolute pro self expanding stent system (ses) was advanced to the target lesion; during deployment of the stent, the wheel only made one click and would not advance any further.When the ses was withdrawn, the stent dislodged in the sheath.The sheath with the stent inside was removed from the patient anatomy.The physician decided to end the procedure, there were no stents implanted.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the distal superficial femoral artery with heavy calcification.The 7.0x100mm absolute pro self expanding stent system (ses) was advanced to the target lesion; during deployment of the stent, the wheel only made one click and would not advance any further.When the ses was withdrawn, the stent dislodged in the sheath.The sheath with the stent inside was removed from the patient anatomy.The physician decided to end the procedure, there were no stents implanted.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was returned for analysis.The reported physical resistance / sticking and the reported difficult or delayed activation was unable to be replicated in a testing environment due to the condition of the returned device.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 similar incidents from this lot.Reportedly, a 0.014¿ abbott bmw guidewire was used.It should be noted the absolute pro self-expanding stent system instructions for use ifu, states: one (1) 0.035" (0.89 mm) diameter guide wire.Use of an undersized guide wire, with insufficient support, may cause kinking in the stent delivery system.The deviation of the ifu appears to have caused/contributed to the reported difficulties.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 deviation of the instructions for use and subsequent circumstances of the procedure as it is likely that use of the undersized 0.014¿ guide wire resulted in the noted kinked stent sheath and the noted multiple kinks on the entire length of the inner member; thus during attempted stent deployment resulted in preventing the shaft lumens from moving freely resulting in the reported physical resistance/sticking thumbwheel and the reported difficult or delayed activation.During withdrawal of the compromised device interaction with the sheath resulted in the noted stent damages (bent/stretched/broken struts, separated distal stent tabs).Based on the reported information and results of the complaint investigation there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.H6: code 2017 failure to follow steps added as 0.014 guide wire was used.

• 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: 20722566
• Report Number: 2024168-2024-13638
• Device Sequence Number: 6602898
• Product Code: NIO
• UDI-Device Identifier: 08717648176098
• UDI-Public: (01)08717648176098(17)270531(10)4062461
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P110028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2025

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 Model Number: 1012535-100
• Device Catalogue Number: 1012535-100
• Device Lot Number: 4062461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/31/2024
• Supplement Date Received by Manufacturer: 01/10/2025
• Initial Report FDA Received Date: 11/19/2024
• Supplement Report FDA Received Date: 01/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 0.014 BMW.
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 81 KG