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

Catalog Number 1012536-80

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Perforation (2001)

Event Date 09/15/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).A partial udi is reported because the lot number was not provided.It is indicated that the device is not returning for evaluation; therefore, a failure analysis of the complaint device could not be completed.The investigation concluded that a definitive cause for the reported patient effects could not be determined.It should be noted that perforation and hypotension are known observed and potential patient effects as listed in the absolute pro instruction for use (ifu).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 issue with respect to manufacture, design or labeling.The 8x100mm absolute pro stent, referenced is filed under a separate manafacturing report number.

Event Description

It was reported that an 8x100 absolute pro stent jumped 4-5 cm during stent deployment at the iliac artery lesion into the descending aorta.Reportedly, there were no issues noted during deployment and part of the stent remained partially at the lesion site.An 8x80mm absolute pro stent was successfully implanted, overlapping the 8x100mm at the external iliac artery lesion without issue.Post procedure, the patient became hypotensive.Angiography was performed and a perforation occurred in the common iliac.Per physician, either stent could have caused the perforation.A non-abbott covered stent treated the perforation successfully.The patient is in stable condition.There was no additional information provided.

• 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 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: 5142625
• MDR Text Key: 28025648
• Report Number: 2024168-2015-05978
• 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: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Report Date: 10/09/2015

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
• Device Catalogue Number: 1012536-80
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/10/2015
• 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): Required Intervention
• Patient Age: 67 YR
• Patient Weight: 71