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

Catalog Number 1011528-18

Device Problems Failure to Advance (2524); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/14/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all relevant information.

Event Description

It was reported that the procedure was to treat the arterial trunk of a calcified renal artery.A 5.0 x 18 mm herculink elite was being advanced when there was resistance with the anatomy while attempting to cross the lesion and the stent dislodged.A balloon catheter was used to remove the dislodged stent.Pre-dilatation was performed with an unspecified balloon and an unspecified stent was successfully deployed to complete the procedure.There was a reported 30 minute delay in procedure, but no adverse patient sequela.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was initially reported as returning for analysis, but has now been reported as not returning because it was discarded at the account.The device was not returned for analysis.It is likely that during the failed attempt to advance, the stent dislodged within the lesion.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.The investigation determined that the reported difficulties are related to circumstances of the procedure.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: 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: 7393954
• MDR Text Key: 104247459
• Report Number: 2024168-2018-02453
• 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: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/09/2018

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 Expiration Date: 08/31/2020
• Device Catalogue Number: 1011528-18
• Device Lot Number: 7091961
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/14/2018
• Initial Date FDA Received: 04/03/2018
• Supplement Dates Manufacturer Received: 05/02/2018
• Supplement Dates FDA Received: 05/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2017
• 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
• Patient Outcome(s): Required Intervention