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

Device Problems Fracture (1260); Material Too Soft/Flexible (4007)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/04/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device is not returning for evaluation.A follow up report will be submitted with all additional relevant information.

Event Description

It was reported that the physician commented that acculink stents are fracturing after implantation.There was no reported adverse patient effect or clinically delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).Correction: brand name.Udi#: in the absence of a reported part number, the udi cannot be calculated.The device was not returned for analysis.The lot history record for this product could not be reviewed and a similar incident query could not be performed because the part and lot numbers were not reported.The investigation was unable to determine a conclusive cause for the reported stent fracture.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Article titled: carotid stent fractures are not associated with adverse events.(b)(4).

Event Description

Subsequent to the initially filed report, the following information was received: the physician indicated that he had analyzed a previous study and demonstrated a detectable higher rate for stent fractures for xact (not acculink as previously reported).The information was provided from an article titled: carotid stent fractures are not associated with adverse events.Additionally, the physician commented that the xact stent is very inflexible and, therefore, improper for tortuous and especially very tortuous lesions.The physician feels this information should be included in the xact instructions for use.No additional information was provided by the physician, as the analysis will be published in a future german medical journal.As the (b)(6) is a closed clinical trial and was monitored by abbott vascular, stent fractures, death, stroke, re-stenosis, myocardial infarction, revascularization were previously reported when the events occurred through the (b)(6) clinical trial.

• 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: 7626430
• MDR Text Key: 112188023
• Report Number: 2024168-2018-04790
• 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,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1