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 Problem Stenosis (2263)

Event Date 11/04/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).There was no reported device malfunction, and the product was not returned.A review of the lot history record revealed no non-conformances or exceptions that would have contributed to the reported event.The investigation concluded that a definitive cause for the reported patient effect could not be determined.The reported patient effect of restenosis is a known observed and potential patient effect as listed in the rx acculink domestic, instructions for use.Although a conclusive cause for the reported patient effect 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 on (b)(6) 2013 the 7-10x40 rx acculink was implanted in the left internal carotid artery (lica).The patient was re-admitted to the hospital on (b)(6) 2015 with carotid artery disease.Magnetic resonance angiogram (mra) found stenosis in the lica.Carotid angiogram on (b)(6) 2015 found 15% in-stent restenosis in the lica.Treatment was an increase in the daily aspirin dose to 325 mg/day.No additional information.

Manufacturer Narrative

(b)(4).The reported patient effects of angina, visual disturbances and arrhythmia are known observed and potential patient effects as listed in the rx acculink domestic instructions for use.

Event Description

Subsequent to the previously filed report, additional information was received that the percentage of stenosis in the left internal carotid artery was 75% via the magnetic resonance angiogram, not 15% as previously reported.The patient also had chest pain, dizziness, transient vision loss, substernal pressure and palpitations.The patient was referred to the cardiologist for follow-up.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: 5265388
• MDR Text Key: 32660942
• Report Number: 2024168-2015-07246
• 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
• Type of Report: Initial,Followup
• Report Date: 01/15/2016

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2014
• Device Catalogue Number: 1011344-40
• Device Lot Number: 3012361
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/11/2015
• Initial Date FDA Received: 12/03/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2013
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 62 YR
• Patient Weight: 77