MAUDE Adverse Event Report: ABBOTT VASCULAR XACT CAROTID STENT SYSTEM; SELF EXPANDING PERIPHERAL STENT SYSTEM

Model Number	82092-01
Medical Device Problem Codes	Off-Label Use (1494); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The stent remains in the patient.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was to treat a moderately calcified, moderately tortuous, 80% stenosed lesion in the left subclavian artery.During the procedure, a suitable stent was not available, so it was decided to implant an 8x30mm xact carotid self-expanding stent system (sess).After the sess was implanted and fully expanded, it was determined that the stent wasn't long enough.The stent length measurement was taken via digital subtraction angiography (dsa), and the length of the stent was determined to be only about 20mm.It was suspected that the 20mm stent was packaged incorrectly in a package labeled 30mm.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 not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents from this lot.A cine was received and reviewed by an abbott vascular clinical specialist.In conclusion, the images provided show the xact stent delivery system, post-deployment measurement as measuring 24.43 mm.This measurement is less than the expected length per the product specification, which states a 30 mm stent should be 30.0 mm ± 2 mm.The stent system packaging shows a label of a length of 30 mm.The diameter is varied across the vessel, but the widest portion is labeled as 6.9 mm.The 8 mm diameter should not foreshorten for expansion into this vessel diameter.A stent system that is undersized for the vessel may foreshorten from overexpansion.There was no damage noted to the device during the inspection prior to use which suggests a product quality issue with respect to manufacture, design or labeling did not contribute to the reported difficulties.Stent shortening may occur due to, but not limited to, anatomical conditions, vessel diameter, stent diameter, vessel preparation, or deployment technique.It is possible that during stent deployment interaction with the moderately calcified, moderately tortuous and 80% stenosed lesion and/or the delivery system was slightly pushed distally as the stent was being deployed resulting in the stent shortening/reported defective device undersized; however, this could not be confirmed.In addition, the curvature of the lesion possibly contributed to an inaccurate measurement of the deployed stent length; however, this could not be confirmed.The investigation determined a conclusive cause for the reported difficulties cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: XACT CAROTID STENT SYSTEM
• Common Device Name: SELF EXPANDING PERIPHERAL STENT SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• 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: 14018096
• Report Number: 2024168-2022-03590
• Device Sequence Number: 4609531
• Product Code: NIM
• UDI-Device Identifier: 08717648010286
• UDI-Public: 08717648010286
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P040038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2022

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 Expiration Date: 04/30/2024
• Device Model Number: 82092-01
• Device Catalogue Number: 82092-01
• Device Lot Number: 1051761
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/16/2022
• Supplement Date Received by Manufacturer: 04/21/2022
• Initial Report FDA Received Date: 04/05/2022
• Supplement Report FDA Received Date: 05/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2021
• 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
• Patient Sex: Unknown