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

Model Number	1012535-100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Pain (1994); Perforation of Vessels (2135)
Date of Event	09/25/2024
Type of Reportable Event	Death
Event or Problem Description
It was reported the procedure was to treat a bifurcation of the aorta.Two non-abbott gore covered stents were placed on the right and left iliac at the bifurcation.The 100% occluded severely calcified external iliac was pre-dilated with a 4.0 armada balloon.A 7.0x100m absolute pro self expanding stent was then deployed.A 7.0x120mm armada 35 balloon dilatation catheter was then used for post dilatation.The balloon was inflated to 6 atmospheres when the patient started feeling pain.The patient was given pain medication; however, then the patient coded (cardiac arrest).Cpr was started including chest compressions.While performing cpr, an angiogram was performed and a perforation was noted in the external iliac artery that was being post dilated.Cpr was performed for 15 minutes, but after ten minutes of cpr there was no pulse.A blood transfusion was administered and balloon dilatation was performed at the perforation to stop the bleeding while they obtained a covered stent.A covered stent was deployed to treat the perforation, but ultimately, the patient was unable to be resuscitated and expired.The physician commented that he should have used the covered stent instead of the absolute (bare metal) stent.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.Electronic lot history record (elhr) 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.The reported patient effects of death, pain and perforation is listed in the absolute pro vascular self-expanding stent system instructions for use as potential adverse effects (e.G., complications) that may be associated with the use of the device.A conclusive cause for the reported death, and the relationship to the product, if any, cannot be determined.A conclusive cause for the reported cardiac arrest, pain and perforation of vessels, and the relationship to the product, if any, cannot be determined.The treatments appears to be related to the operational context of the procedure.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.

• 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: 20465235
• Report Number: 2024168-2024-12195
• Device Sequence Number: 7353059
• Product Code: NIO
• UDI-Device Identifier: 08717648176098
• UDI-Public: (01)08717648176098(17)260331(10)3041161
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P110028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 10/16/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2026
• Device Model Number: 1012535-100
• Device Catalogue Number: 1012535-100
• Device Lot Number: 3041161
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/25/2024
• Initial Report FDA Received Date: 10/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/11/2023
• 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: Death
• Patient Age: 81 YR
• Patient Sex: Female
• Patient Weight: 54 KG