MAUDE Adverse Event Report: AV-TEMECULA-CT ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM; SELF EXPANDING STENT SYSTEM

Catalog Number 1012538-60

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

Patient Problems Hematoma (1884); Pain (1994); Rash (2033); Swelling (2091)

Event Date 09/01/2013

Event Type  Injury  

Event Description

It was reported that the patient has leg pain that is worse now than it was prior to the stenting procedure in (b)(6) 2013.In (b)(6) 2013, an absolute pro stent was implanted in the left iliac artery.That night, or the following day, the patient had itching, hives, increased leg pain, pulsating/throbbing leg pain.The generalized itching and hives lasted about three to four months, but the leg pain is continuing.The left leg is tender to touch.Her physicians are aware of the patient condition, but the patient was told this is normal and that she has neuropathy.No further diagnostics nor treatment have been performed.Her ankle is swollen and her leg just doesn't feel right.The leg has bruising and broken veins.She had broken veins previously but it was not this bad.Reportedly, she cannot eat shell fish because it makes her itchy with hives, but she did not tell the vascular surgeon about this prior to her stenting procedure.The vascular surgeon told her that the iliac lesion was ballooned ten to eleven times during the procedure.There was no additional information provided.

Manufacturer Narrative

Date of event, implant date: estimated dates (reported as (b)(6) 2013).There was no reported device malfunction, and the product was not returned.The reported patient effect of pain is a known observed and potential patient effect as listed in the absolute pro instruction 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.

• Brand Name: ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM
• Type of Device: SELF EXPANDING 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: 3933037
• MDR Text Key: 18728395
• Report Number: 2024168-2014-04509
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110028
• 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: 07/10/2014

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
• Device Catalogue Number: 1012538-60
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/10/2014
• Initial Date FDA Received: 07/14/2014
• 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): Other
• Patient Age: 54 YR
• Patient Weight: 86