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

Catalog Number 1011505-15

Device Problems Device Dislodged or Dislocated (2923); Material Deformation (2976)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 01/10/2019

Event Type  Injury  

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 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
• Type of Device: STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 8262722
• MDR Text Key: 133689257
• Report Number: 2024168-2019-00460
• Device Sequence Number: 1
• Product Code: NIN
• UDI-Device Identifier: 08717648078378
• UDI-Public: 08717648078378
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: 1011505-15
• Device Lot Number: 7050161
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/10/2019
• Initial Date FDA Received: 01/18/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 52