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

Catalog Number 1010132-30

Device Problems Positioning Failure (1158); Difficult to Remove (1528); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/17/2013

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for evaluation and confirmed the reported partial deployment.A search of the complaint handling database was performed and no other incidents were identified from this lot for this issue.Although an expanded records review found no non-conforming material reports from this lot, the potential for a product deficiency does exist.Continued assessment of this issue per site operating procedures is being performed, corrective and preventive actions will addressed per quality system protocol.

Event Description

It was reported that the procedure was to treat a lesion in the internal carotid, below a bifurcation.After the 6-8/30 acculink ii self expanding stent system (sess) was advanced, an attempt was made to deploy the stent, but the release became stuck.Four attempts were made, but the stent could not be deployed.There were no adverse patient effects and no clinically significant delay in the procedure.Additional information reported that there must have been some resistance felt during removal of the sess from the anatomy.After removal, 2mm of the stent was exposed.A new acculink sess was used to complete the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).Concomitant products: guide wire: 0.035x300 stiff; sheath: long 90 cm; other: introducer 6fr, emboshield nav6.The device is expected to be returned for evaluation.It has not yet been received.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: 3593104
• MDR Text Key: 11636573
• Report Number: 2024168-2014-00425
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P040012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/28/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2015
• Device Catalogue Number: 1010132-30
• Device Lot Number: 3022261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/25/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2013
• 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
• Treatment: EMBOLIC PROTECTION DEVICE: EZ (BOSTON SCIENTIFIC)