MAUDE Adverse Event Report: AV-TEMECULA-CT RX HERCULINK ELITE STENT SYSTEM; RENAL STENT SYSTEM

Catalog Number 1011487-15

Device Problems Difficult to Remove (1528); Unstable (1667); Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/24/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Patient weight is (b)(6) kg.(b)(4).Visual and functional inspection was performed on the returned device.The mangled and unstable stent was confirmed.The failure to advance was unable to replicate in a testing environment.The resistance was also unable to be replicated due to the condition of the returned device.The investigation determined that the reported difficulties were due to case circumstances.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported revealed no other incidents.Additionally, it was reported that the herculink elite was being used to treat the proximal superior mesenteric artery.It should be noted that rx herculink elite renal and biliary stent system instructions for use (ifu) states: the rx herculink elite renal stent system is indicated for use in patients with atherosclerotic disease of the renal arteries following sub-optimal percutaneous transluminal renal angioplasty (ptra) of a de novo or restenotic atherosclerotic lesion (less than 15 mm in length) located within 10 mm of the renal ostium and with a reference vessel diameter of 4.0 - 7.0 mm.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.

Event Description

It was reported that during the procedure to treat a mildly calcified, de novo lesion in a very tortuous, 90 degree angled osteal proximal superior mesenteric artery, a 4.0mm x 15mm x 135cm rx herculink elite renal stent system was advanced through a 6fr non-abbott 55cm sheath without resistance and was advanced to the lesion without issue, but the rx herculink elite was unable to completely cross the lesion due to the 90 degree vessel angle.Thus, the rx herculink elite was pulled back to the osteum for better positioning before attempting to cross again.When pulling the rx herculink elite back to the osteum without resistance, the stent struts became caught on the distal edge of the sheath, resulting in the stent being mangled and the stent shifting distally outside of the balloon markers, but no stent dislodgement.In order to retract the rx herculink elite through the sheath, the rx herculink elite was advanced slightly then maneuvered gently and completely back inside of the sheath, then was retracted through the sheath and out of the anatomy without resistance.The procedure was successfully completed using a 4.0x18 rx herculink elite with the same sheath.There were no adverse patient effects and no occurrence of a clinically significant delay.No additional information was provided.

• Brand Name: RX HERCULINK ELITE STENT SYSTEM
• Type of Device: RENAL 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: 6111628
• MDR Text Key: 60556968
• Report Number: 2024168-2016-08062
• Device Sequence Number: 1
• Product Code: NIN
• UDI-Device Identifier: 08717648078194
• UDI-Public: (01)08717648078194(17)180430(10)5050461
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110001
• 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
• Report Date: 11/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2018
• Device Catalogue Number: 1011487-15
• Device Lot Number: 5050461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2015
• 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: 6FR COOK ANSEL 55CM
• Patient Age: 72 YR
• Patient Weight: 71