MAUDE Adverse Event Report: AV-TEMECULA-CT XACT CAROTID STENT SYSTEM

Catalog Number 82090-01

Device Problems Break (1069); Material Separation (1562)

Patient Problems Syncope (1610); Bradycardia (1751); Low Blood Pressure/ Hypotension (1914); Dizziness (2194); Stenosis (2263)

Event Date 06/19/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Dates estimated.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 index procedure was (b)(6) 2017 with an unspecified xact stent implanted in the right carotid artery; there was no reported issue with the procedure and no adverse patient effect.At the routine follow up visit (b)(6) 2018 the patient reported falling 5 feet from a ladder onto his head/neck area; since that time then he has had dizziness/fainting spells every 3-4 weeks.A second procedure was performed for the level 4 grade stent fracture with high grade stenosis; an unspecified xact stent was implanted.It was noted that the patient experienced symptomatic bradycardia with heart rate in the 40's, blood pressure 80/40, then hypotensive 80/50; atropine and fluid boluses, phenyleprine were given and the symptoms improved; the patient was discharged on post-op day 3.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was not returned for analysis.Cine images were reviewed by abbott vascular medical affairs.The reviewer states: the stent fracture was confirmed.A filter was seen in the distal vessel and a small balloon dilatation catheter (bdc) inflated in the stent.The bdc has a waist at the fracture site and is not fully expanded.A second larger bdc is seen inflated at the fracture site and does fully expand.There is a much improved vessel diameter and a nice tapered expansion of the stent with no evidence of stent fracture.The bradycardia is most likely due to the bdc inflation.The lot history record (lhr) for this product could not be reviewed and a similar incident query could not be performed because the product was not returned for evaluation and the lot number was not provided.The investigation was unable to determine a conclusive cause for the reported stent fracture.Based on the reported information, the stent fracture may be related to material stress resulting from blunt force trauma to the area; however, this could not be confirmed.The reported patient effects of hypotension, restenosis, syncope, dizziness and bradycardia are listed in the xact instruction for use as known potential adverse events associated with use of carotid stents and embolic protection systems.The subsequent patient effects appear to be related to case circumstances.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

Subsequent to the initial medwatch report filed, the following additional information was received: the 8-6 x 40 mm xact stent was implanted on (b)(6) 2017.The patient had routine follow-up visit on 05/02/2018 which showed good velocities.On (b)(6) 2018 the patient presented with symptoms of dizziness/fainting spells and a high grade stenosis/stent fracture was revealed.The following day a stent procedure was performed as treatment.On (b)(6) 2018 at a follow-up visit velocities were back in line.No additional information was provided.

• Brand Name: XACT CAROTID STENT SYSTEM
• Type of Device: CAROTID STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 7923145
• MDR Text Key: 122213684
• Report Number: 2024168-2018-07539
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• PMA/PMN Number: P040038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 82090-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 73 YR