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

Model Number 82086-01

Device Problems Material Separation (1562); Difficult or Delayed Activation (2577)

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

Event Date 08/28/2021

Event Type  Injury  

Manufacturer Narrative

The stent remains in patient.The device will not be returned for evaluation.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 performed on (b)(6) 2021 to treat a tortuous vessel in the left carotid artery with a certain included angle, and the neck range of motion at the stent site was large.An emboshield nav6 embolic protection system (eps) filter was opened and an unspecified balloon was used for dilatation with the filter.The 9.0x40mm xact self-expanding stent system (sess) didn't fully expand when the stent was deployed and an additional balloon was used to further deploy the stent and implant it in the vessel.The patient was re-examined on (b)(6) 2021 as a routine procedure 2-3 months after operation and that's when the stent was noted to be separated in two pieces.The stent remains implanted and no treatment was performed.The patient's blood flow is fine having no effect on the patient.There was no adverse patient effect and there was 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.Potential causes for activation/deployment failure include, but are not limited to, manufacturing, anatomical conditions; deployment technique and/or damage to the device deployment mechanisms (handle components/shaft lumens/ratchet), or inadequate pre-dilatation of the stricture.Additionally, potential factors that may contribute to stent fractures include, but are not limited to, processing and/or handling in manufacturing, handling during preparation for use, lesion characteristics, procedural technique, product size selection, severe torqueing or kinking of stent (material stress/ fatigue), interaction with the accessory devices, lesion and/or anatomy.Fatigue from artery dynamics (pulsatile flow) and motion may also contribute to stent fractures during or after the procedure.It is possible that interaction with the tortuous anatomy resulted in the reported activation/deployment failure; however this cannot be confirmed.The treatment appears to be related to the operational context of the procedure as an additional balloon was used to further deploy the stent and implant it in the vessel.In addition, it is possible that over post-dilation of the stent resulted in the reported material separation/stent break; however this cannot 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: 12879212
• MDR Text Key: 281288409
• Report Number: 2024168-2021-10822
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 08717648010224
• UDI-Public: 08717648010224
• 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: 01/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2024
• Device Model Number: 82086-01
• Device Catalogue Number: 82086-01
• Device Lot Number: 1051061
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2021
• 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
• Treatment: EMBOSHIELD EMBOLIC PROTECTION SYSTEM
• Patient Outcome(s): Required Intervention