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

Catalog Number 1011528-18

Device Problems Difficult To Position (1467); Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/17/2014

Event Type  Injury  

Event Description

It was reported that the procedure was to treat a lesion in the renal artery.Pre-dilatation was performed with a 4.0x15mm unspecified balloon dilatation catheter (bdc).The 5.0mmx18mmx135cm herculink elite renal stent system failed to cross the lesion reportedly due to interactions with the patient's anatomy and was removed without reported issue.Additional pre-dilatation was performed with an unspecified bdc.The same herculink elite renal stent system was re-advanced; however, resistance was met with the non-abbott 6-french sheath and the stent implant dislodged.The dislodged stent implant was retrieved to the humeral artery and surgical cut-down was performed to retrieve the dislodged stent implant from the patient's anatomy.The decision was made to complete the procedure at that time, and reportedly, no future procedure is planned to treat the target lesion.There was no reported adverse patient sequela; however, there was a reported clinically significant delay in the procedure due to the surgical procedure performed to retrieve the dislodged stent implant.There was no additional information provided.

Manufacturer Narrative

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

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for evaluation.The reported stent dislodgement was confirmed.The reported difficulty positioning in the introducer sheath could not be tested due to the condition of the returned device.The reported failure to cross could not be replicated in a lab environment as it was based on case circumstances.Based on visual analysis of the returned device, there is no indication of a product deficiency.A review of the lot history record revealed no non-conformances.A query of the electronic complaint handling database revealed no other incidents reported from this lot.It should be noted that the herculink elite instructions for use (ifu) states: "do not attempt to pull an unexpanded stent back through the introducer sheath/guiding catheter; dislodgment of the stent from the balloon may occur." based on the information reviewed, there is no indication of a product deficiency.

• Brand Name: RX HERCULINK ELITE RENAL STENT SYSTEM
• Type of Device: STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 462
• Manufacturer (Section G): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; abbott vascular; 26531 ynez road; temecula CA 92591 462
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 4203009
• MDR Text Key: 5147996
• Report Number: 2024168-2014-07000
• Device Sequence Number: 1
• Product Code: NIN
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P110001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2017
• Device Catalogue Number: 1011528-18
• Device Lot Number: 4062361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2014
• 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: DIL CATH: 4.0X15MMSHEATH: 6-FRENCH
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR