MAUDE Adverse Event Report: ABBOTT VASCULAR RX HERCULINK ELITE STENT SYSTEM; STENT, RENAL

Catalog Number 1011540-18

Device Problems Leak/Splash (1354); Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920); Device Dislodged or Dislocated (2923)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/09/2022

Event Type  malfunction  

Manufacturer Narrative

Date of event ¿ estimated.The device location was not provided, and it is unknown if the device is returning for analysis.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat an unknown lesion, in an unknown artery.A 7.0x18mm herculink elite balloon-expandable stent (bes) was advanced to the lesion and at the moment of deploying the stent, contrast was noted in the vessel instead of inflating the balloon.No additional information was provided.

Event Description

Subsequent to the initial filed report, the following information was received: it was reported that there was no contrast liquid that flowed out in the patient vessel at the moment of releasing the stent.The stent was noted to be crimped improperly on the balloon; however, an attempt was made to advance the stent delivery system (sds) on the balloon to the lesion in the renal artery.The sds would not advance over the wire.The device was removed and the procedure was successfully completed using two new herculink elite stent systems (6x18mm, 7x18mm) with no reported patient effect or procedural delay.The was no additional information provided.

Manufacturer Narrative

H6: medical device problem code 2017 use after damage 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 identified no other incidents.It was reported that the physician noted from the beginning that the stent was not correctly crimped on the balloon, but he tried to advance it nonetheless, without success.It should be noted that the rx herculink elite peripheral stent system instructions for use specifies: prior to using the rx herculink elite¿ peripheral stent system, carefully remove the system from the package and inspect for bends, kinks, and other damage.Verify that the stent is located between the radiopaque balloon markers.Do not use if any defects are noted.It is unknown if the ifu deviation directly caused or contributed to the reported event.The investigation was unable to determine a conclusive cause for the reported difficulties.Difficult to advance/position (guide wire resistance) may be attributed to several factors including, but are not limited to, product placement technique, guiding catheter support, inner diameter of guide wire lumen, outer diameter of the guide wire, condition of the guide wire, damage to the catheter or accumulation of blood or contrast.Stent dislodgement may be attributed to several factors including, but not limited to, improper or inadequate crimping at the time of manufacture, handling of the stent during preparation, and interaction with the anatomy, accessory devices and/or previously implanted stents.In this case, it is possible the reported stent dislodgement was due to inadvertent mishandling during sheath/stylet removal or unpackaging of the device, causing the reported stent dislodgement.It is also possible that a buildup of procedural contaminants may have contributed to the reported difficult to advance (guide wire resistance); however, without the device to examine, this cannot be confirmed.There is no indication of a product quality issue with respect to manufacture, design, or labeling.H6: medical device problem code 1354 - removed.

• Brand Name: RX HERCULINK ELITE STENT SYSTEM
• Type of Device: STENT, RENAL
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 16473593
• MDR Text Key: 310618791
• Report Number: 2024168-2023-02139
• Device Sequence Number: 1
• Product Code: NIN
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P110001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 04/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1011540-18
• Device Lot Number: 1100561
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2021
• 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 Sex: Female