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

Catalog Number XRX04009T

Device Problem Physical Resistance (2578)

Patient Problems Intimal Dissection (1333); Stroke/CVA (1770); Occlusion (1984)

Event Date 02/26/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4) during processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4) it is indicated that the device is not returning for evaluation; therefore a failure analysis of the complaint device could not be completed.The reported difficulties appear to be due to case circumstances.A review of the lot history record revealed no non-conformances that would have contributed to the reported event.A query of the electronic complaint handling database revealed no other similar incidents from this lot.Based on the reviewed information, there is no indication of a product quality issue with respect to manufacture, design, or labeling.The reported patient effects of dissection, occlusion, and stroke are known observed and potential patient effect as listed in the xact carotid stent system instruction for use (ifu).

Event Description

It was reported that the procedure was to treat a heavily tortuous and heavily calcified internal carotid artery below the bifurcation.An emboshield nav6 was deployed distal to the lesion.Pre-dilatation was performed with a 3.0 x 20 mm trek balloon catheter.A 9-7 x 40 mm xact stent was advanced to the lesion but could not cross and was removed.Additional pre-dilatation was performed with a 5 x 20 mm viatrac balloon catheter.Angiography was performed and flow was present distal to the lesion.The xact stent was again advanced to the lesion and there was some difficulty crossing; however, the stent did cross and was successfully deployed which caused the artery to kink distal to the stent.Post deployment angiography showed an occlusion at the carotid bifurcation which occluded the left internal carotid artery.The patient was taken to surgery.The patient suffered a middle cerebral stroke and the neurological deficit is unknown.There was a clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).

Event Description

Subsequent to the previously filed medwatch report, additional information was received stating that the patient is at (b)(6) rehabilitation with essentially dense hemiplegia.

• 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: 5514573
• MDR Text Key: 40812705
• Report Number: 2024168-2016-01769
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P040038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2018
• Device Catalogue Number: XRX04009T
• Device Lot Number: 5021061
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2015
• 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 Outcome(s): Hospitalization; Required Intervention; Disability