MAUDE Adverse Event Report: AV-TEMECULA-CT RX HERCULINK ELITE STENT SYSTEM; RENAL STENT SYSTEM

Catalog Number	1011499-15
Medical Device Problem Codes	Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/29/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).The device was not returned for analysis.A review of the lot history record and complaint history of the reported lot could not be conducted, because the lot number was not provided.The reported failure to cross and stent dislodgement appear to be related to interaction with the patient calcification.It should be noted that the rx herculink elite renal and biliary stent system instructions for use states: the rx herculink elite renal stent system is indicated for use in patients with atherosclerotic disease of the renal arteries.Additionally, the warning section states that applying excessive force to the stent delivery system can potentially result in loss or damage to the stent and delivery system components.The use of force was likely applied due to case circumstances related to heavy calcification.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling of the device.
Event or Problem Description
It was reported that the procedure was to treat a heavily calcified lesion in the right common femoral artery (cfa).The lesion was pre-dilated with a balloon catheter.The 6.0x15mm rx herculink elite stent delivery system (sds) was advanced with force applied; however, failed to cross the lesion.During withdrawal of the sds, the stent dislodged.A snare device was used to retrieve the dislodged stent from the anatomy.The procedure was completed with a new herculink elite.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.

• Brand Name: RX HERCULINK ELITE STENT SYSTEM
• Common Device Name: RENAL STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8330890
• Report Number: 2024168-2019-01051
• Device Sequence Number: 985719
• Product Code: NIN
• UDI-Device Identifier: 08717648078194
• UDI-Public: 08717648078194
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 02/12/2019

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 Catalogue Number: 1011499-15
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2019
• Initial Report FDA Received Date: 02/12/2019
• 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
• Patient Age: 78 YR