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

Catalog Number 1011344-40

Device Problem Physical Resistance (2578)

Patient Problem Stenosis (2263)

Event Date 11/27/2013

Event Type  Injury  

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 restenosis is a known observed and potential adverse event as listed in the instructions for use (ifu).Based on the reviewed information, no product deficiency was identified.

Event Description

It was reported that on (b)(6) 2012, during a heavily calcified right internal carotid artery (ica) stenting procedure, there was some difficulty with the advancement of the acculink stent delivery system (sds) times two attempts.An xact sds was advanced and would not cross the lesion due to the patients anatomy.Another non-study stent would not cross.Then the same acculink sds was advanced again and was successfully implanted to treat the lesion.On (b)(6) 2013, increased velocities were noted in the right ica and per angiogram, 80% in-stent restenosis was noted.On (b)(6) 2013, the patient was hospitalized for lesion revascularization.An xact stent was implanted.On (b)(6) 2013, the event was noted to be resolved and the patient was discharged home.There was no additional information provided.

Manufacturer Narrative

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

• 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: 3572972
• MDR Text Key: 11557479
• Report Number: 2024168-2014-00288
• 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: 12/20/2013

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2012
• Device Catalogue Number: 1011344-40
• Device Lot Number: 0100161
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/20/2014
• Initial Date FDA Received: 01/13/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/22/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2010
• 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
• Patient Age: 75 YR
• Patient Weight: 57