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

Catalog Number 82096-01

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 06/13/2019

Event Type  Death  

Manufacturer Narrative

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.The reported patient effect of death is listed in the xact instructions for use as a known potential patient effect associated with the use of the device.Based on the case information, a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.Exemption number (b)(4)-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 omnilink elite stent referenced is filed under a separate medwatch report number.

Event Description

It was reported that on (b)(6) 2019 the omnilink elite stent was implanted in the subclavian artery and the xact stent was implanted in the internal carotid artery.The procedure was completed successfully.Reportedly, 8 days later, the patient expired.The cause of death is reported as unknown.No additional information was provided.

• Brand Name: XACT CAROTID
• Type of Device: SELF EXPANDING PERIPHERAL STENT SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 8828979
• MDR Text Key: 152300462
• Report Number: 2024168-2019-10388
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 08717648010323
• UDI-Public: 08717648010323
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: P040038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: 82096-01
• Device Lot Number: 7100561
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2017
• 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): Death
• Patient Age: 70 YR
• Patient Weight: 74