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

Catalog Number 82090-01

Device Problems Entrapment of Device (1212); Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/30/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The customer reported the device was discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported the procedure was to treat a lesion in the left internal carotid artery.The sheath used in the procedure was damaged (kinked) however as this was the last sheath available, the procedure was continued.The 8.0 x 40 mm xact self expanding stent system (sess) was advanced to the lesion however the stent was unable to completely deploy and the device became stuck.A cut down was made in the carotid artery and the sess was removed with the partially deployed stent.The procedure was completed with arthroscopy.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.

Manufacturer Narrative

Exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.The device was not returned for evaluation.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 incidents and/or complaints.The investigation determined that the reported difficulties were likely due to case circumstances.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: XACT CAROTID
• Type of Device: SELF EXPANDING PERIPHERAL STENT SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9083435
• MDR Text Key: 161216080
• Report Number: 2024168-2019-11879
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 08717648010262
• UDI-Public: 08717648010262
• 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
• Type of Report: Initial,Followup
• Report Date: 10/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Catalogue Number: 82090-01
• Device Lot Number: 9072561
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 96