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

Catalog Number 1011344-40

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

Patient Problems Stroke/CVA (1770); Embolism (1829); Transient Ischemic Attack (2109)

Event Date 08/04/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date of birth-estimated: provided as october 1941.Weight-estimated.(b)(4).A partial udi is being reported because the lot number was not provided.There was no reported device malfunction, and the product was not returned.The reported patient effects of embolism, cerebrovascular accident and transient ischemic attack (tia) are known observed and potential patient effects as listed in the rx acculink, domestic, instructions for use.Although a conclusive cause for the reported patient effects and the relationship to the product, if any, cannot be determined, there is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that the moderate to heavily calcified, 80 to 90% lesion in the right internal carotid artery (rica) was predilated with a 4x20 balloon dilatation catheter on (b)(6) 2015.The 7x10x40 acculink was implanted in the rica without incident.The patient was properly heparinized during the procedure.The activated clotting time was in good therapeutic range above 250 and the emboshield nav6 was removed.No thrombus was seen at the emboshield nav6.There were no device issues during the procedure.After the procedure, the patient was talking and his arms were moving, but he was noted to have a mild transient ischemic attack because the patient was not squeezing with the hand.Later that day the left arm and leg of the patient went flaccid and the patient was diagnosed with a cerebrovascular accident or stroke.The stroke team was called.A computerized tomography (ct) scan of the head found debris in the middle cerebral artery per the neurologist.It is unknown when the debris was dislodged, but it was not suspected to be thrombus.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: 5039763
• MDR Text Key: 24516111
• Report Number: 2024168-2015-04970
• 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: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Report Date: 08/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 1011344-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/04/2015
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 113