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

Catalog Number 82090-01

Device Problem Difficult to Remove (1528)

Patient Problem Vasoconstriction (2126)

Event Date 01/23/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.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 lesion located in an unspecified vessel.The xact stent was deployed without issues.However, when retracting the device, the delivery catheter tip got caught mid-stent, causing a vessel spasm.Nitroglycerin was administered.The device was "jiggled" and was able to be removed without damage to the implanted stent.The patient is fine.No additional information was provided.

Manufacturer Narrative

Internal file number - (b)(4).The incident information was reviewed; however, the product was not returned to abbott vascular for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no other similar incidents reported from this lot.The investigation determined the reported difficult to remove appears to be related to operational circumstances of the procedure.Based on the reported information, it is likely that manipulation of the delivery catheter during retraction caused the delivery catheter to encountered resistance and get caught with the implanted stent.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.

• 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: 8348319
• MDR Text Key: 136479491
• Report Number: 2024168-2019-01193
• 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: 03/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Catalogue Number: 82090-01
• Device Lot Number: 8120561
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention