MAUDE Adverse Event Report: AV-TEMECULA-CT ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM; SELF EXPANDING STENT SYSTEM

Catalog Number 1012536-100

Device Problems Detachment Of Device Component (1104); Improper or Incorrect Procedure or Method (2017); Material Deformation (2976)

Patient Problems Occlusion (1984); Foreign Body In Patient (2687)

Event Date 01/27/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Use in incorrect anatomy and failure to follow steps/instructions.The stent remains in the anatomy.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

It was reported that on (b)(6) 2018, the patient had presented after ventricular tachycardia (v-tach) arrest with an occluded right arm arterio-venous (av) fistula with no flow.Percutaneous intervention was initiated.There was no pre-dilatation performed.A 6 french (6f) sheath was placed and an absolute pro stent delivery system (sds) was advanced without issue to the fistula.Deployment was initiated at the intended area.Once the stent was one half way deployed, the physician decided to move the stent to another area.There had been no issue with deployment.The physician attempted to pull the delivery system back and then push forward attempting to move the half-deployed stent.The then fully deployed stent fractured into pieces and the stent had become crushed within the av fistula.There was no blood flow through this stent.As treatment, on (b)(6) 2018, surgery was performed and a temporary catheter was placed.The previous av fistula, containing the absolute pro, remained in the patient.On (b)(6) 2018, the patient had another episode of ventricular tachycardia, treated with advanced coronary life support measures.The patient expired.Per physician, the v-tach and patient expiration were unrelated to the absolute pro stent.The v-tach and subsequent patient death were related to the patients total clinical condition.There was no additional information provided regarding this issue.

Manufacturer Narrative

(b)(4).The device was not returned for analysis.The reported difficulties and subsequent patient effects appear to be due to use error.The absolute pro vascular instruction for use (ifu) states: do not attempt to pull a partially-expanded stent back through the introducer sheath or guiding catheter.The stent is not designed for recapturing.The stent is not designed for repositioning once the stent has apposed the vessel.Once the stent is apposed to the vessel, it is not recommended to remove the stent with the delivery system.Additionally, the ifu states: the absolute pro vascular self-expanding stent system is indicated for improving luminal diameter in patients with de novo or restenotic atherosclerotic lesions in the native common iliac artery and native external iliac artery with reference vessel diameters between 4.3 mm and 9.1 mm and lesion lengths up to 90 mm.In this case, it is likely that attempting to reposition the partially deployed stent in the vessel caused the reported difficulties.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.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM
• Type of Device: SELF EXPANDING 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: 7293369
• MDR Text Key: 100835010
• Report Number: 2024168-2018-01359
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110028
• 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: 03/22/2018

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1012536-100
• Device Lot Number: 042061
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/01/2018
• Initial Date FDA Received: 02/23/2018
• Supplement Dates Manufacturer Received: 03/14/2018
• Supplement Dates FDA Received: 03/22/2018
• 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
• Treatment: SHEATH 6FHEPARIN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 80 YR
• Patient Weight: 73