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

Catalog Number 82099-01

Device Problem Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/25/2018

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 was received.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 moderately calcified left internal carotid artery into the common carotid.A 6f 90 cm non-abbott sheath was advanced and an emboshield nav6 embolic protection system was placed in the anatomy.Pre-dilatation was performed with a non-abbott balloon catheter and then a second pre-dilatation was performed with a 10 x 20 mm non-abbott balloon catheter.The catheter felt a little tight advancing through the sheath but there was no resistance felt.An unknown size xact self-expanding stent system (sess) was advanced to the lesion without issue and the stent was deployed, however, the placement was misjudged and the stent was placed partially out of the lesion.A 10s x 20 mm xact sess was advanced to the lesion and it felt a little tight but there was no resistance.The stent was deployed; however, during removal, the catheter could not be pulled back into the sheath.The sheath was advanced distally over the xact and encapsulated the catheter but the xact still could not be pulled out of the sheath.The entire system was removed as a single unit.There was no clinically significant delay in procedure and no adverse patient effects.No additional information was provided.

Manufacturer Narrative

Internal file number - (b)(4).Evaluation summary: visual and functional inspection was performed on the returned device.The difficulty was not confirmed as the introducer sheath was not returned.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 of the reported lot revealed no other incidents.The investigation was unable to determine a conclusive cause for the reported difficulty.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

Pre-dilatation was performed with an unknown sized viatrac balloon catheter and then a second pre-dilatation was performed with a 10 x 20 mm viatrac balloon catheter.

• 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
• Manufacturer (Section G): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 7277882
• MDR Text Key: 100525188
• Report Number: 2024168-2018-01188
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: 82099-01
• Device Lot Number: 6121361
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/07/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/25/2018
• Initial Date FDA Received: 02/16/2018
• Supplement Dates Manufacturer Received: 02/28/2018
• Supplement Dates FDA Received: 03/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2016
• 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
• Patient Age: 61 YR