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

Catalog Number	1011505-15
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Material Deformation (2976)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	01/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported lot revealed no other similar incidents.The investigation determined that the reported difficulties and subsequent patient effects were due to case circumstances.Reportedly, the unspecified guide lost positioning.On attempting to reposition the guide, contact with the stent was made which resulted in the stent struts flaring and the stent dislodging in the femoral artery.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the procedure was performed to treat a calcified lesion in the left renal artery.A 7.0 x 15 mm herculink elite stent delivery system was being advanced to the lesion with no resistance when the unspecified guide lost positioning.On attempting to reposition the guide, contact with the stent was made which resulted in the stent struts flaring and the stent dislodging in the femoral artery.A cut down was performed to remove the dislodged stent.The patient lost 400 ml of blood during the cut down.The access site / cut down site was closed using two proglide closure devices.No further intervention was performed for the renal artery at the time.Post procedure the patient was reported to be doing well.No additional intervention was provided.

• Brand Name: RX HERCULINK ELITE STENT SYSTEM
• Common Device Name: STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8262722
• Report Number: 2024168-2019-00460
• Device Sequence Number: 16664237
• Product Code: NIN
• UDI-Device Identifier: 08717648078378
• UDI-Public: 08717648078378
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 01/18/2019

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 Expiration Date: 04/30/2020
• Device Catalogue Number: 1011505-15
• Device Lot Number: 7050161
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2019
• Initial Report FDA Received Date: 01/18/2019
• 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: 73 YR
• Patient Weight: 52