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

Catalog Number 1011522-18

Device Problems Inflation Problem (1310); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/28/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.

Event Description

It was reported the procedure was to treat a non-calcified, mildly tortuous arterial vertebrae.A 4.0 x 18mm herculink elite stent delivery system crossed the lesion and as it was pressurized it was noted that contrast appeared on the outside of the balloon.The balloon failed to inflate.The balloon was not punctured.The device was removed.Another same size stent was used to successfully complete the procedure.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.

Manufacturer Narrative

(b)(4).Visual and functional inspections were performed on the returned stent.The inflation issue and leak were confirmed.The issues were confirmed to be due to the tear noted at the guide wire exit notch.The rx herculink elite instruction for use, states: the rx herculink elite peripheral stent system is intended to open lumen restrictions in the biliary tree, renal arteries, and protected peripheral arteries.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.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.

• Brand Name: RX HERCULINK ELITE STENT SYSTEM
• Type of Device: 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: 7373601
• MDR Text Key: 103833049
• Report Number: 2024168-2018-02207
• Device Sequence Number: 1
• Product Code: NIN
• Combination Product (y/n): N
• Reporter Country Code: AR
• PMA/PMN Number: P110001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: 1011522-18
• Device Lot Number: 6021761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/05/2018
• Initial Date FDA Received: 03/27/2018
• Supplement Dates Manufacturer Received: 04/25/2018
• Supplement Dates FDA Received: 04/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2016
• 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