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

Device Problems Device Damaged by Another Device (2915); Material Deformation (2976)

Patient Problem Embolism (1829)

Event Date 08/19/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Unique device identifier (udi): the udi is unknown because the part number and lot number were not provided.The stent remains in the vessel.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 determined the reported difficulties and treatment appear to be related to circumstances of the procedure.The patient effect of embolism is a known and potential patient effect as listed in the omnilink elite electronic instructions for use.Although a conclusive cause and a relationship between the reported patient effect of embolism and the product, if any, cannot be determined, there is no indication that the issue is related to the design, manufacture or labeling of the device.The supera sds referenced is filed under mfr report# 2024168-2015-05328.

Event Description

It was reported that on (b)(6) 2015 two omnilink elite stents were deployed in the total occlusion of the common iliac and external iliac lesions without issue.The patient was admitted overnight due to distal clots and was administered tissue plasminogen activator (tpa).On (b)(6) 2015 a supera stent was implanted in the proximal superficial femoral artery.While retracting the stent delivery system (sds) over the command guide wire, resistance was noted at the distal tip of the sds sheath.While viewing angiographically, something 'snapped' and the tip became separated, but remained on the guide wire.The sds was retracted and the tip was removed; however, it was suspected that the sds tip may have caught on a stent strut of the implanted omnilink elite stent, causing damage to the stent strut.A 7 x 29 mm omnilink stent was deployed, covering the damaged stent strut to allow flow.Post procedure the vessel result was noted as very good and the patient condition was good.There was no reported adverse patient sequela.There was no reported clinically significant delay in the procedure.No additional information was provided.

• 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: 5078095
• MDR Text Key: 25833395
• Report Number: 2024168-2015-05350
• 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: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 09/15/2015

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/20/2015
• Initial Date FDA Received: 09/15/2015
• 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): Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Weight: 79