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

Catalog Number 1012631-19

Device Problems Deflation Problem (1149); Difficult or Delayed Positioning (1157); Difficult To Position (1467); Difficult to Remove (1528); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/03/2015

Event Type  Injury  

Event Description

It was reported that the procedure was to treat a lesion in the subclavian artery.Pre-dilatation was performed using a 6.0mmx20mmx135cm armada 35 balloon dilatation catheter (bdc).The 8.0mmx19mmx135cm omnilink elite stent delivery system (sds) was advanced to the target lesion without reported issue; however, during deployment of the stent implant, the balloon dog-boned and could not be deflated.Multiple attempts were made to deflate the sds balloon using multiple indeflators and multiple syringes; however, the sds could not be deflated.An attempt was made to advance a stiff guide wire into the sds; however, resistance was met advancing the guide wire.Multiple stiff guide wires were advanced proximal end first alongside the sds in an attempt to puncture the balloon; however, these attempts were unsuccessful.The patient was placed under unplanned full general anesthesia.The access site was changed from the right groin to the left brachial and attempts were made to puncture the balloon from the other side using multiple stiff guide wires; however, these attempts were unsuccessful.A biopsy needle was attempted to puncture the balloon; however, these attempts were unsuccessful.The access site was changed to the left groin and a stiff guide wire with the aid of a support catheter was used to puncture the balloon.During withdrawal, the sds interacted with the deployed stent implant; however, the sds was able to be removed.The deployed stent implant appeared to be slightly damaged and malapposed; therefore, post-dilatation was performed using a 7.0mmx40mmx135cm armada 35 bdc.There was a clinically significant delay in the procedure and the patient was kept hospitalized overnight for unplanned observation.The patient has since been discharged and is doing well.There was no additional information provided.

Manufacturer Narrative

(b)(4).The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

(b)(4).Evaluation summary: the returned device analysis confirmed the difficulty to deflate.A search of the complaint handling database was performed and no other incidents were identified from this lot for deflation difficulties.A search of the lot history record for this specific lot indicated no related non-conformance records; however, based on an expanded investigation, it was determined that the difficulty in deflation for this unit may be related to manufacturing.Corrective and preventive actions to address this have been implemented and the performance of these devices will continue to be monitored.

• 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 462
• Manufacturer (Section G): CLONMEL, IRELAND REG# 9616693; 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: 4632007
• MDR Text Key: 5571431
• Report Number: 2024168-2015-01598
• 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: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2018
• Device Catalogue Number: 1012631-19
• Device Lot Number: 4110641
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/13/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2014
• 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): Hospitalization; Required Intervention
• Patient Age: 46 YR
• Patient Weight: 32