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

Model Number	1012535-100
Medical Device Problem Codes	Material Separation (1562); Mechanical Jam (2983); Activation Failure (3270)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	09/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the superficial femoral artery (sfa).During the deployment of a 7x100mm absolute pro self-expanding stent (ses) the thumbwheel was noted to jam causing the stent to only be partially deployed.The physician decided to remove the ses and the introducer sheath as a single unit, however 2mm of the stent were noted to separate in the anatomy.The separated stent was embedded to the vessel wall using balloon angioplasty.There were no adverse patient sequela and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Additional Manufacturer Narrative
The device was returned for analysis.The reported stent material separation was able to be confirmed.The reported mechanical jam and the reported activation failure were 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 incidents from this lot.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 during advancement interaction with the anatomy and/or inadvertent mishandling resulted in the noted device damages (jacket stretch marks, kinked stent sheath) preventing the shaft lumens from moving freely; thus, resulting in the reported mechanical jam and the reported activation/deployment failure.Manipulation of the compromised device by disassembling the handle resulted in the noted bent i-beam and the noted bent hypotube likely contributing to the reported difficulties.Further manipulation of the compromised device ultimately resulted in the reported stent material separation/noted stent damages (bent, stretched, broken struts, separated distal stent tabs).As reported, the separated stent was embedded to the vessel wall using balloon angioplasty.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.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the superficial femoral artery (sfa).During the deployment of a 7x100mm absolute pro self-expanding stent (ses) the thumbwheel was noted to jam causing the stent to only be partially deployed.The physician decided to remove the ses and the introducer sheath as a single unit; however, 2mm of the stent was noted to separate in the anatomy.The separated stent was embedded to the vessel wall using balloon angioplasty.There were no adverse patient sequela and no clinically significant delay in the procedure.Subsequent to the initially filed report, device return analysis revealed that the handle was received disassembled.The account confirmed that the handle was disassemble in attempts to fully deploy the stent.No additional information was provided.

• 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: 20395244
• Report Number: 2024168-2024-11817
• Device Sequence Number: 6566200
• Product Code: NIO
• UDI-Device Identifier: 08717648176098
• UDI-Public: (01)08717648176098(17)270531(10)4062461
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 11/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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
• Date Returned to Manufacturer: 10/01/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/18/2024
• Supplement Date Received by Manufacturer: 10/15/2024
• Initial Report FDA Received Date: 10/08/2024
• Supplement Report FDA Received Date: 11/05/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown