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

Catalog Number 1011343-40

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

Patient Problem Death (1802)

Event Date 06/11/2013

Event Type  Death  

Event Description

Although requested, there was no additional information provided.

Event Description

It was reported that on (b)(6) 2012, the patient underwent a stenting procedure with placement of a 6-8 x 40 mm rx acculink stent in the mildly calcified left internal carotid artery.On (b)(6) 2013, the patient collapsed and passed away at home.Cause of death is not known and no autopsy was performed.Additional information has been requested.

Manufacturer Narrative

(b)(4).The stent remains in the patient.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

(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.A review of the lot history record revealed no non-conformances that would have contributed to the reported event.The results of the query of similar incidents in the complaint handling database for this lot did not indicate a manufacturing issue.The reported patient effect of death is listed in the rx acculink, domestic, instructions for use.A query of the electronic complaint handling database indicated there had been no similar incidents reported for this lot.Based on the information reviewed, there is no indication of a product deficiency.

• Brand Name: RX ACCULINK CAROTID STENT SYSTEM
• Type of Device: CAROTID STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 462
• Manufacturer (Section G): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; abbott vascular; 26531 ynez road; temecula CA 92591 462
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 3595870
• MDR Text Key: 4134343
• Report Number: 2024168-2014-00459
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2014
• Device Catalogue Number: 1011343-40
• Device Lot Number: 2061961
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/07/2014
• Initial Date FDA Received: 01/28/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/12/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2012
• 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: 66 YR
• Patient Weight: 60