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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Intimal Dissection (1333); Embolism (1829); Hemorrhage/Bleeding (1888); Ischemia (1942); Pain (1994); Perforation (2001)

Event Date 08/19/2014

Event Type  Injury  

Event Description

It was reported through a research article identifying the herculink elite stent that may be related to the following: discomfort during balloon inflation, retroperitoneal hemorrhage, renal artery perforation, arterial and aortic dissection, atheromatous embolization, and renal infarctions.Specific patient information is documented as unknown.Details are listed in the attached article, titled "scai expert consensus statement for renal artery stenting appropriate use".

Manufacturer Narrative

(b)(4).The devices are not returning and there was no reported device malfunction.Review of the lot history record could not be conducted because the lot numbers were not provided.The reported patient effects of dissection, embolism, hemorrhage, perforation, kidney infarct, and pain are known observed and potential patient effects as listed in the rx herculink elite instructions for use.Although a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined, there is no indication of a product quality deficiency with respect to manufacturing, design or labeling.Sahil a.Parikh,1 md, facc, fscai ; mehdi h.Shishehbor, do, mph, facc, fscai; bruce h.Gray, do, fscai; christopher j.White, md, facc, fscai and michael r.Jaff, do, facc, fscai.(catheterization and cardiovascular interventions 00:00-00 (2014)): scai expert consensus statement for renal artery stenting appropriate use.

• 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 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: 4164185
• MDR Text Key: 4872518
• Report Number: 2024168-2014-06610
• 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: Literature
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 08/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Disability