MAUDE Adverse Event Report: AV-TEMECULA-CT OMNILINK ELITE PERIPHERAL STENT SYSTEM

Device Problems Difficult to Insert (1316); Device Operates Differently Than Expected (2913)

Patient Problems Intimal Dissection (1333); Hematoma (1884)

Event Date 12/07/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The location of the reported device was not provided; however, when information is received the investigation will be completed.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that an issue with the omnilink elite stent delivery system occurred during a procedure to treat an aortic and iliac dissection.The introducer sheath size had to be upgraded from a 6 french to a 7 french sheath on the left side and there was an ensuing large hematoma.There was concern over the upgrade of the sheath size that was required during the procedure as the patient was medicated with heparin and clopidogrel for her cardiac procedure.The stent delivery system packaging states these sizes will go through a 6fr sheath.No additional information was provided.It has not been confirmed at this time if the omnilink elite caused the dissection or if it was treating a dissection.

Manufacturer Narrative

(b)(4).A udi is not being reported because the part and lot numbers were not provided.The device was not returned for analysis.The lot history record (lhr) for this product could not be reviewed and a similar incident query could not be performed because the product was not returned for evaluation and the part and lot numbers were not reported.The investigation was unable to determine a conclusive cause for the reported difficulties as the products were not returned for analysis.Dissection and hemorrhage are listed in the omnilink elite instruction for use as potential adverse effects associated with the use of the device.However, it has not been confirmed at this time if the omnilink elite caused the dissection or if it was treating a dissection.Abbott vascular is aware of the failure mode of difficult to insert, and patient effects of dissection and hemorrhage; however a similarity regarding the root cause could not be identified.While a definitive cause cannot be determined in this incident, no product malfunction, failure or deterioration of characteristic or performance of the device or inadequacy in the labeling and/or instructions for use was identified.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: OMNILINK ELITE PERIPHERAL STENT SYSTEM
• Type of Device: PERIPHERAL 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: 6213687
• MDR Text Key: 63555074
• Report Number: 2024168-2016-09344
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P110043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/22/2017

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2016
• Initial Date FDA Received: 12/29/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/22/2017
• 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
• Treatment: SHEATH: 6FR, 7FR
• Patient Outcome(s): Other