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

Catalog Number 1011528-18

Device Problems Difficult to Remove (1528); Failure to Advance (2524); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/15/2020

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation.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 other complaints reported from this lot.Based on the information provided, the reported difficulties appear to be due to circumstances of the procedure.The resistance during advancement and removal was likely due to interaction with the anatomy.Additionally, it is likely that during the attempt to advance against resistance, the stent became compromised on the balloon resulting in material deformation to the stent.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

It was reported that a 5x18mm herculink elite stent delivery system (sds) failed to cross the lesion, so the sds was removed.However, during removal, the balloon and stent opened without inflation or deployment due to possible interaction during removal.A non-abbott stent was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

• 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: 10639180
• MDR Text Key: 210219895
• Report Number: 2024168-2020-08305
• Device Sequence Number: 1
• Product Code: NIN
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P110001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Catalogue Number: 1011528-18
• Device Lot Number: 9031861
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/18/2019
• 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: 72 YR