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

Catalog Number 1010127-20

Device Problem Inaccurate Delivery (2339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/21/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Concomitant medical products: sheath: 6f terumo destination, embolic protection: emboshield nav6 6 eps.The device was not returned for analysis.A review of the lot history record revealed no non-conformance's that would have contributed to the reported event.A query of the complaint handling database revealed no other similar incidents reported from this lot.The investigation was unable to determine a cause for the reported inaccurate delivery.It may be possible that anatomical conditions contributed to the inaccurate delivery; however, this could not be confirmed.The additional treatment was due to case circumstances.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 performed to treat a concentric de novo lesion in the proximal internal carotid artery with 95-99% narrowing and 8-10mm of mild calcification.An emboshield nav6 embolic protection system was advanced and placed distal to the lesion.Subsequently, a non-abbott balloon dilatation catheter (bdc) was advanced to the lesion and pre-dilation was performed.A 6x20mm acculink rx self-expanding stent system was then advanced to the lesion and the stent was slowly deployed by the physician.During deployment, a distal dislocation of the stent was observed.The physician pulled at the delivery system to keep the stent in the target lesion; however, the implanted stent covered 50% of the target lesion, and the remaining portion of the stent was almost fully implanted distal to the target lesion, with narrowing at the proximal stent entry.A 5.0x20mm viatrac bdc was used to post-dilate the narrowing.Finally, a 9x7x40mm xact stent was implanted, with a 10mm overlap into the implanted acculink stent and approximately 20mm over the carotid bifurcation.There was no adverse patient sequela and no reported clinically significant delay in the procedure.No additional information was 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: 7646041
• MDR Text Key: 112596697
• Report Number: 2024168-2018-05106
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P040012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 06/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: 1010127-20
• Device Lot Number: 7082161
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2017
• 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): Required Intervention