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

Model Number 1011487-18

Device Problems Difficult to Remove (1528); Failure to Advance (2524); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/22/2020

Event Type  Injury  

Manufacturer Narrative

The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was performed to treat a de novo lesion with heavy tortuosity and 70% stenosis in the right vertebral artery.A 4.0 x 18mm herculink elite stent deliver system (sds) was being advanced; however, after the non-abbott guidewire crossed the vertebral artery, the sds failed to advance to the target lesion due to anatomy.Therefore, a 2.5mm balloon was used to dilate the lesion but the sds still failed to advance.The sds was withdrawn but also met resistance with anatomy and the stent dislodged.A snare was used to successfully retrieve the dislodged stent.The procedure ended at this point.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Visual analysis was performed on the returned product.The reported failure to advance and difficulty removing from the anatomy was not tested as it was based on procedural circumstances.The stent dislodgment was confirmed.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.The investigation determined that the reported difficulties and subsequent treatment to remove the dislodged stent were due to case circumstances.It is likely that anatomical conditions contributed to the reported failure to cross, difficulty removing and stent dislodgment.It is likely that the stent became compromised on the balloon during the failed attempt to advance resulting in resistance and dislodgment during removal.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, RENAL
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10426326
• MDR Text Key: 203528285
• Report Number: 2024168-2020-06906
• Device Sequence Number: 1
• Product Code: NIN
• UDI-Device Identifier: 08717648077845
• UDI-Public: 08717648077845
• Combination Product (y/n): N
• PMA/PMN Number: P110001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: 1011487-18
• Device Catalogue Number: 1011487-18
• Device Lot Number: 0031061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2020
• Date Manufacturer Received: 09/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention