MAUDE Adverse Event Report: AV-TEMECULA-CT RX HERCULINK 14 PLUS STENT SYSTEM; BILIARY STENT SYSTEM

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

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994); Swelling (2091)

Event Date 01/01/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).There was no reported device malfunction and the product was not returned.The reported patient effects of hemorrhage and pain are known observed and potential patient effects as listed in the herculink elite instructions for use.Although a conclusive cause for the reported patient effect and the relationship to the product, if any, cannot be determined, there is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that the herculink plus stent was implanted in the renal artery in (b)(6) 2001.The patient began having flank/kidney pain, lower extremity swelling, abdominal and low back swelling, hematuria and dysuria in (b)(6) 2014.The cause of these issues is unknown at this time.The patient will continue to obtain medical care and diagnostics from his physicians.The hematuria and dysuria ended around (b)(6) 2015.No additional information was provided.

• Brand Name: RX HERCULINK 14 PLUS STENT SYSTEM
• Type of Device: BILIARY 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: 5196292
• MDR Text Key: 30205613
• Report Number: 2024168-2015-06525
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 11/02/2015

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/08/2015
• Initial Date FDA Received: 11/02/2015
• 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): Other
• Patient Age: 58 YR
• Patient Weight: 98