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

Catalog Number 1011504-18

Device Problems Difficult To Position (1467); Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/09/2015

Event Type  malfunction  

Event Description

It was reported that the patient underwent a procedure to treat a target lesion in the proximal mesenteric artery.The herculink elite stent delivery system was advanced to the target lesion, but was unable to cross to the target lesion.The herculink elite delivery system caught on the guide catheter during removal.A 4.5 x 20 mm non-abbott stent was used to treat the target lesion.There was no reported adverse patient effect and no clinically significant delay.There was no additional information provided.

Manufacturer Narrative

(b)(4).Incorrect anatomy.Evaluation summary: the device was returned, inside a non-abbott guiding catheter, for evaluation and the reported difficulty to remove was confirmed.The reported failure to cross and resistance could not be confirmed as it was based on case circumstances.Based on visual, dimensional and functional analysis of the returned device, there is no indication of a product deficiency.A review of the lot history record revealed no non-conformances.A query of the electronic complaint handling database revealed no other similar incidents reported from this lot.It was reported that the herculink elite was being used to treat the proximal mesenteric artery.It should be noted that the herculink elite stent system instructions for use states: the rx herculink elite biliary stent system is intended for palliation of malignant strictures in the biliary tree.In this case, it could not be determined if the off-label use caused or contributed to the reported difficulties.Based on the information reviewed, there is no indication of a product deficiency.

Manufacturer Narrative

(b)(4).It was reported that the herculink elite was being used to treat the proximal mesenteric artery.It should be noted that the herculink elite 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 following sub-optimal percutaneous transluminal renal angioplasty (ptra) of a de novo or restenotic atherosclerotic lesion (15 mm in length) located within 10 mm of the renal ostium and with a reference vessel diameter of 4.0 - 7.0 mm.In this case, it could not be determined if the off-label use caused or contributed to the reported difficulties.Based on the information reviewed, there is no indication of a product deficiency.

• Brand Name: RX HERCULINK ELITE STENT SYSTEM
• Type of Device: RENAL STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 462
• Manufacturer (Section G): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; abbott vascular; 26531 ynez road; temecula CA 92591 462
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 4741121
• MDR Text Key: 5704112
• Report Number: 2024168-2015-02446
• Device Sequence Number: 1
• Product Code: NIN
• 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: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2017
• Device Catalogue Number: 1011504-18
• Device Lot Number: 5011261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2015
• 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
• Treatment: GUIDE CATHETER: 6FRENCH X 55 CM IMA LAUNCHER
• Patient Age: 87 YR
• Patient Weight: 47