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

Model Number	1011487-15
Medical Device Problem Codes	Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	02/14/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
It was reported that the procedure was to treat a de novo, mildly calcified, heavily tortuous and 90% stenosed lesion in the right renal artery.The herculink elite stent delivery system (sds) was advanced but after several attempts, failed to cross the lesion.When the sds was removed from the body, it was found that the stent had dislodged and was left in the patient's deep femoral artery.The stent was embedded in the vessels.There was no adverse patient sequela or a clinically significant delay in procedure.Another 4x15 coronary stent was used to finish the procedure.There was no additional information provided.
Additional Manufacturer Narrative
Visual analysis was performed on the returned product.The reported failure to advance was not tested as it was based on case 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 embed the stent in the vessel were due to case circumstances.It is likely that anatomical conditions contributed to the reported failure to cross and stent dislodgment.It is likely that the stent became compromised on the balloon after several attempts to cross the mildly calcified, heavily tortuous and 90% stenosed lesion resulting in dislodgment during removal.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Na.

• 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: 11376316
• Report Number: 2024168-2021-01456
• Device Sequence Number: 19778503
• Product Code: NIN
• UDI-Device Identifier: 08717648077838
• UDI-Public: 08717648077838
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P110001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: 1011487-15
• Device Catalogue Number: 1011487-15
• Device Lot Number: 0101661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2021
• Initial Date Received by Manufacturer: 02/14/2021
• Supplement Date Received by Manufacturer: 04/05/2021
• Initial Report FDA Received Date: 02/24/2021
• Supplement Report FDA Received Date: 04/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention