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

Catalog Number 1011540-18

Device Problems Difficult to Remove (1528); Difficult to Advance (2920); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/15/2018

Event Type  malfunction  

Manufacturer Narrative

(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 investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat an 80% stenosed lesion in the right renal artery.Resistance was felt when advancing a 7x18mm herculink elite stent delivery system (sds) through a 6f guide catheter.Resistance removing the sds was felt with the guide catheter.Force was required to remove the sds and the stent separated (dislodged) from the balloon.The stent dislodgement occurred outside of the guide catheter.There were no adverse patient effects and there was no reported clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Internal file number - (b)(4).Evaluation summary: analysis was performed on the returned device.The reported stent dislodgment was confirmed.The reported positioning and removing from the guiding catheter could not be replicated in a testing environment as it was based on procedural circumstance.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar incidents from this lot.The reported difficulty advancing and removing the device from the guiding catheter and stent dislodgment appear to be related to case circumstance due to interaction with the stent and guiding catheter.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design 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
• MDR Report Key: 8162085
• MDR Text Key: 130328277
• Report Number: 2024168-2018-09680
• Device Sequence Number: 1
• Product Code: NIN
• Combination Product (y/n): N
• PMA/PMN Number: P110001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Catalogue Number: 1011540-18
• Device Lot Number: 8050962
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2019
• Date Manufacturer Received: 02/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDING CATHETER: 6F