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

Catalog Number 1011534-18

Device Problems Difficult or Delayed Positioning (1157); Material Rupture (1546); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/09/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The stent remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The additional herculink elite referenced is filed under a separate medwatch report number.

Event Description

It was reported that the procedure was to treat an eccentric lesion in the moderately tortuous, 70% to 80% stenosed renal artery.A 6.0 x 18 mm herculink elite stent delivery system (sds) was selected for the procedure.The sds was advanced to the lesion and during deployment, the stent implant slipped distally out of position and was deployed only partially in the lesion.A second 6.0 x 18 mm herculink elite stent was selected to cover the remainder of the lesion.The sds was advanced to the lesion and deployed.After deployment it was observed that the stent implant had not fully expanded due to the amount of stenosis in the lesion.The sds balloon was then inflated again to 18 atmospheres and ruptured.It was determined that a high pressure balloon catheter will need to be used to fully expand the stent implant.This will be done during another procedure that has not been scheduled yet.There was a ten-minute delay in the procedure due to the need to implant a second stent.No addition information was provided.

Manufacturer Narrative

(b)(4).The device was not returned for analysis.The deployment difficulties were likely due to anatomical conditions.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 lot revealed no other incidents.It should be noted that rx herculink elite renal and biliary stent system instructions for use states: balloon pressures should be monitored during inflation.Do not exceed rated burst pressure (rbp) as indicated on product label.Use of pressures higher than specified on product label may result in a ruptured balloon with possible vessel / duct damage or perforation.The investigation determined that the reported difficulties were due to case circumstances.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The armada 35 pta catheter referenced is filed under a separate medwatch report number.

Event Description

The following additional information was received: the patient returned for a follow-up procedure in an attempt to open up the 2nd herculink elite stent.An 8.0 x 20 mm armada 35 percutaneous transluminal angioplasty (pta) catheter was selected for the procedure.The pta catheter was placed, but the balloon ruptured on the first inflation and failed still to crack the stenosis.The patient was sent for surgery and is doing well.No other 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: 6488956
• MDR Text Key: 72936885
• Report Number: 2024168-2017-03107
• Device Sequence Number: 1
• Product Code: NIN
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P110001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2018
• Device Catalogue Number: 1011534-18
• Device Lot Number: 5051261
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: STENT: 6.0 X 18 MM HERCULINK ELITE
• Patient Outcome(s): Hospitalization; Required Intervention