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

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

Patient Problems Stroke/CVA (1770); Myocardial Infarction (1969); Occlusion (1984); Transient Ischemic Attack (2109); Heart Failure (2206); Stenosis (2263); Prolapse (2475)

Event Date 08/06/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Date of event has been estimated.Udi could not be reported because the part and lot numbers were not reported.Date of implant has been estimated.The device was not returned for evaluation.A review of the electronic lot history record (elhr), was not performed since the part and lot numbers were not reported and the product was not returned for analysis.The reported patient effects of cerebrovascular accident, myocardial infarction, occlusion, tia-transient ischemic attack, heart failure and stenosis are listed in rx acculink carotid stent system electronic instructions for use as known patient effects of the stenting procedure.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.Literature attachment: cguard micronet covered stent vs.Acculink: basal, 30d dw mri and 1y clinical evaluation in 100 randomized patients: the siberia trial.[(b)(4)].

Event Description

It was reported via a literature article identifying acculink carotid stents that may be related to myocardial infarction, stroke, restenosis, congestive heart failure, occlusion, transient ischemic attack, plaque prolapse and treatment with medication.Details are listed in the attached report titled, interim results of the randomized study in carotid artery revascularization: cguard micronet covered stent vs.Acculink: basal, 30d dw mri and 1y clinical evaluation in 100 randomized patients: the siberia trial.

Manufacturer Narrative

Internal file number - (b)(4).Correction: conclusion code 67 was added.

• Brand Name: 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
• MDR Report Key: 8348361
• MDR Text Key: 136490171
• Report Number: 2024168-2019-01194
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• PMA/PMN Number: P040012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/21/2019

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/07/2019
• Initial Date FDA Received: 02/18/2019
• Supplement Dates Manufacturer Received: 02/21/2019
• Supplement Dates FDA Received: 02/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability