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

Model Number	1011487-18
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/22/2020
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 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due to anatomy.Therefore, a 2.5mm balloon was used to dilate the lesion but the sds still failed to advance.The sds was withdrawn but also met resistance with anatomy and the stent dislodged.A snare was used to successfully retrieve the dislodged stent.The procedure ended at this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.
Additional 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
• Common Device Name: STENT, RENAL
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10426326
• Report Number: 2024168-2020-06906
• Device Sequence Number: 16798939
• Product Code: NIN
• UDI-Device Identifier: 08717648077845
• UDI-Public: 08717648077845
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P110001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2020

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: 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
• Initial Date Received by Manufacturer: 08/04/2020
• Supplement Date Received by Manufacturer: 09/21/2020
• Initial Report FDA Received Date: 08/19/2020
• Supplement Report FDA Received Date: 10/16/2020
• 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