MAUDE Adverse Event Report: ABBOTT VASCULAR INC. XACT; STENT, CAROTID

Model Number	82087-01
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat a lesion in the left internal carotid artery with heavy calcification.An emboshield filter was advanced without issues.Pre-dilatation was performed with a 4.0x20mm viatrac balloon at 14 atmospheres (atms).The 9.0x30mm xact stent delivery system (sds) was advanced onto the barewire and deployed.However, the nose cone of the xact delivery system broke off inside the stent upon removal.Another guide wire was able to advance thru the delivery system; however, a balloon could not get through.The patient was then taken to the operating room for endarterectomy and was able to cut the distal portion of the barewire and the filter.The carotid artery was then cut out with the delivery system, stent implant and the separated nose cone with it.The patient has been discharged and doing well.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 not returned for analysis.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.A cine was received and reviewed by an abbott vascular clinical specialist: the images provided did confirm that the nosecone of the xact delivery system did break off inside the stent upon removal.It appears the distal portion of the stent was not fully expanded which may have caused the resistance during pullback resulting in the nose cone detachment.Without imaging of the lesion prep and visualization of the lesion immediately following stent deployment a probable cause can only be partially determined.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 upon device removal the tip of the device inadvertently got caught with the deployed stent; thus resulting in the reported tip material separation.As reported, the patient was then taken to the operating room for an endarterectomy and was able to cut the distal portion of the barewire and the filter.The carotid artery was then cut out with the delivery system, stent implant and the separated nose cone with it.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.H11 correction: update to mfg narrative to include review of cine received.
Additional Manufacturer Narrative
The device was not returned for analysis.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.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 upon device removal the tip of the device inadvertently got caught with the deployed stent; thus resulting in the reported tip material separation.As reported, the patient was then taken to the operating room for an endarterectomy and was able to cut the distal portion of the barewire and the filter.The carotid artery was then cut out with the delivery system, stent implant and the separated nose cone with it.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.E4 correction - initial report sent to fda updated from no to yes.G2 additional information - report source "user facility" added.Attachment: medwatch report.

• Brand Name: XACT
• Common Device Name: STENT, CAROTID
• 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: 21015381
• Report Number: 2024168-2024-15304
• Device Sequence Number: 6678087
• Product Code: NIM
• UDI-Device Identifier: 08717648010231
• UDI-Public: (01)08717648010231(17)270630(10)4071561
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P040038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/22/2025

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: 82087-01
• Device Catalogue Number: 82087-01
• Device Lot Number: 4071561
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/07/2024
• Supplement Date Received by Manufacturer: 01/14/2025; 01/22/2025
• Initial Report FDA Received Date: 12/25/2024
• Supplement Report FDA Received Date: 01/22/2025; 01/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/15/2024
• 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: EMBOSHIELD NAV 6.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 93 KG