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

Catalog Number 1011534-18

Device Problems Improper or Incorrect Procedure or Method (2017); Expiration Date Error (2528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/17/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).The stent remains in the patient.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat a renal artery with a 6.0x18mm herculink elite renal stent system.However, after a 5.0x18mm herculink elite renal stent was implanted, the physician noted that the wrong size was used.The carton label on the box indicated a 6.0x18mm herculink elite renal stent system but the pouch label indicated a 5.0x18mm herculink elite renal stent system.The physician decided to conclude the procedure using the 5mm stent as it was already in the lesion.There was 10% residual stenosis but the physician deemed re-intervention not necessary.Patient results were satisfactory.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Internal file number: (b)(4).The device was not returned to abbott vascular for analysis.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 similar incidents from this lot.It should be noted that rx herculink elite renal and biliary stent system instructions for state: carefully inspect the rx herculink elite renal stent system prior to use to verify that the stent has not been damaged in shipment and that the device dimensions are suitable for the specific procedure.Take care to avoid unnecessary handling.The investigation was unable to determine a conclusive cause for the reported device marking issues.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.

• 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
• MDR Report Key: 8337366
• MDR Text Key: 136133550
• Report Number: 2024168-2019-01091
• Device Sequence Number: 1
• Product Code: NIN
• Combination Product (y/n): N
• PMA/PMN Number: P110001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: 1011534-18
• Device Lot Number: 7071961
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 76