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

Catalog Number 1011493-12

Device Problems Off-Label Use (1494); Difficult to Remove (1528); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/20/2019

Event Type  malfunction  

Manufacturer Narrative

Exemption number (b)(4) permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.The emboshield nav6 referenced is filed under a separate medwatch report number.The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.Na.

Event Description

It was reported that the emboshield nav6 barewire was advanced to the left vertebral artery.A viatrac balloon dilatation catheter (bdc) was traversed over the barewire and the bdc was used without incident.The bdc was removed.The 5.0x12 mm herculink elite stent delivery system (sds) was loaded on to the barewire, but was unable to be advanced on the wire.The sds did not enter the introducer sheath.The sds was unable to be removed from the barewire, so the barewire and sds were removed together as a unit.Outside the anatomy, the sds was able to be removed from the barewire with a fair amount of force.Another barewire and another herculink were used to complete the procedure without further incident.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Event Description

It was reported that the emboshield nav6 barewire was advanced to the left vertebral artery.A viatrac balloon dilatation catheter was traversed over the barewire and the bdc was used without incident.The bdc was removed.The 5.0x12 mm herculink elite stent delivery system was loaded on to the barewire, but was unable to be advanced on the wire.The sds did not enter the introducer sheath.The sds was unable to be removed from the barewire, so the barewire and sds were removed together as a unit.Outside the anatomy, the sds was able to be removed from the barewire with a fair amount of force.Another barewire and another herculink were used to complete the procedure without further incident.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.Visual and functional analysis was performed on the returned product.The reported difficulty was not able to be 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 incidents.It was reported that the herculink elite was intended to be used in the left vertebral artery.It should be noted that the herculink elite instruction for use states: the rx herculink elite renal stent system is indicated for use in patients with atherosclerotic disease of the renal arteries.In this case, the off-label use does not appear to have contributed to this complaint.The investigation was unable to determine a cause for the reported difficulties.It may be possible that the rx herculink elite sds and barewire were not coaxially aligned during insertion, resulting in the reported difficulty; however, this could not be confirmed.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: 8791266
• MDR Text Key: 151127428
• Report Number: 2024168-2019-10080
• Device Sequence Number: 1
• Product Code: NIN
• UDI-Device Identifier: 08717648078002
• UDI-Public: 08717648078002
• 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,health
• Type of Report: Initial,Followup
• Report Date: 09/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: 1011493-12
• Device Lot Number: 8101761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2019
• Initial Date Manufacturer Received: 06/20/2019
• Initial Date FDA Received: 07/15/2019
• Supplement Dates Manufacturer Received: 08/28/2019
• Supplement Dates FDA Received: 09/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: EMBOSHIELD NAV6 BAREWIRE
• Patient Age: 69 YR
• Patient Weight: 97