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

Model Number 82092-01

Device Problems Off-Label Use (1494); Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/16/2022

Event Type  malfunction  

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 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.

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
• Type of Device: 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
• MDR Text Key: 288657424
• Report Number: 2024168-2022-03590
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 08717648010286
• UDI-Public: 08717648010286
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P040038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 04/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1