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

Catalog Number 1011493-15

Device Problems Unstable (1667); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/27/2018

Event Type  malfunction  

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 was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

It was reported that the procedure was to treat a lesion located in the right renal.The 5.0 x 15 mm rx herculink elite stent delivery system (sds) was advanced to the lesion; however, would not cross.After retraction of the sds from the patient, the stent implant was observed to have slipped back on the sds balloon.A non-abbott sds was used successfully to treat the patient with no adverse patient effects, or clinically significant delay in the procedure reported.No additional information was provided.

Manufacturer Narrative

(b)(4).A visual and dimensional inspection was performed on the returned device.The reported unstable or loose stent was unable to be confirmed.The reported failure to advance was unable to be replicated in a testing environment as it was based on operational circumstances.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 similar incidents reported for the lot.The investigation was unable to determine a conclusive cause for the reported unstable or loose stent implant.There is no indication of a product quality issue with respect to 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: 7363835
• MDR Text Key: 103416683
• Report Number: 2024168-2018-02089
• Device Sequence Number: 1
• Product Code: NIN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: 1011493-15
• Device Lot Number: 6071161
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/20/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2016
• 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
• Patient Age: 68 YR
• Patient Weight: 63