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

Catalog Number 1011487-12

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/21/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.It is indicated that the device is not returning for evaluation; therefore a failure analysis of the complaint device could not be completed.Based on the reported information, there is no indication of a product quality issue with respect to manufacture, design, or labeling.The investigation determined that the reported failure to advance and stent movement appear to be related to case circumstances.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no similar incidents from this lot.Based on the reviewed information, there is no indication the issue was caused by, or related to the design, manufacture or labeling of the device.

Event Description

It was reported that the procedure was to treat a moderately tortuous and mildly calcified left renal artery.A 4.0 x 12 mm herculink elite stent delivery system was being advanced when at an acute angle in the vessel there was resistance and the stent implant moved proximally on the balloon.The balloon was slightly inflated to keep the stent in place and was pulled back into the guiding catheter and the devices were removed as a single unit.Another herculink elite was successfully used to complete the procedure.There was no clinically significant delay in procedure and no adverse patient effects.No additional information was provided.

• 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: 4973986
• MDR Text Key: 23589251
• Report Number: 2024168-2015-04479
• 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
• Report Date: 07/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2018
• Device Catalogue Number: 1011487-12
• Device Lot Number: 5050161
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2015
• 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: 78 YR