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

Catalog Number 1011337-30

Device Problems Positioning Failure (1158); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/19/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).Date of event has been estimated.The device was not returned for analysis.It should be noted that the rx acculink instruction for use states: the rx acculink carotid stent system, used in conjunction with the abbott vascular embolic protection system specified below, is indicated for the treatment of patients at high and standard risk for adverse events from carotid endarterectomy who require carotid revascularization.The investigation was unable to determine a cause for the reported difficulty.The lot history record (lhr) for this product could not be reviewed and a similar incident query could not be performed because the product was not returned for evaluation and the lot number was not reported.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

It was reported that the procedure was to treat a lesion located in the popliteal artery.There was an issue deploying the acculink carotid stent system, once it reached the target lesion.The device was used off-label in the incorrect anatomy.A 5 x 4 mm acculink was used to complete the procedure.No additional information can be provided.

• 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 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: 6552977
• MDR Text Key: 74793222
• Report Number: 2024168-2017-04006
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 08717648076190
• UDI-Public: (01)08717648076190
• 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: company representative
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 05/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1011337-30
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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