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

Catalog Number	1011493-12
Medical Device Problem Codes	Off-Label Use (1494); Difficult to Remove (1528); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G9: 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.The emboshield nav6 referenced in b5 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 or Problem 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 or Problem 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.
Additional 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
• Common Device Name: STENT, RENAL
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 8791266
• Report Number: 2024168-2019-10080
• Device Sequence Number: 19492583
• Product Code: NIN
• UDI-Device Identifier: 08717648078002
• UDI-Public: 08717648078002
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P110001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 06/20/2019
• Supplement Date Received by Manufacturer: 08/28/2019
• Initial Report FDA Received Date: 07/15/2019
• Supplement Report FDA Received Date: 09/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EMBOSHIELD NAV6 BAREWIRE
• Patient Age: 69 YR
• Patient Weight: 97