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

Catalog Number 1011493-15

Device Problem Unintended System Motion (1430)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/14/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Patient weight was estimated as (b)(6) lbs.The stent remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

It was reported that this was a percutaneous intervention treating a right renal, moderately calcified lesion.A command guide wire and herculink elite renal stent delivery system (sds) were advanced to the right renal lesion site without issues.During stent deployment, it is thought that the command guide wire had torque built up and pushed against the herculink stent, causing the stent to move being deployed in the aorta, completely outside the intended area.Reportedly, there was no stent jumping during deployment, it appeared pushed by the command guide wire.The physician decided to leave the deployed stent at that location and the procedure was ended.It was confirmed that there was no resistance felt with the anatomy during advancement of the guide wire and no torqueing issues with the guide wire during advancement.There was also no resistance felt between the two devices during advancement of the sds over the guide wire.No further intervention was performed and there was no treatment reported.There was no adverse patient sequela.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was not returned for analysis.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 was unable to determine a cause for the reported difficulty.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: 8143189
• MDR Text Key: 129649591
• Report Number: 2024168-2018-09460
• 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: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Catalogue Number: 1011493-15
• Device Lot Number: 6111461
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2016
• 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
• Treatment: GUIDE WIRE: HI-TORQUE COMMAND 300 CM
• Patient Outcome(s): Other
• Patient Age: 65 YR
• Patient Weight: 82