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

Catalog Number 11003-59

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

Patient Problem Thrombosis (2100)

Event Date 08/16/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical devices: 6 f terumo introducer sheath, omnilink elite 9mm stent delivery system.The stent remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The other omnilink elite device is filed under a separate manufacturing report number.

Event Description

It was reported that, via a 6 f terumo introducer sheath, an omnilink elite 7mm stent was successfully implanted in the external iliac artery, heavily calcified lesion.An omnilink elite 9mm stent delivery system (sds), for intended implant in the internal iliac artery, was advanced into the 6f terumo introducer sheath with significant resistance.Once the omnilink 9mm sds was at the previously implanted 7mm stent, the 9mm stent dislodged.The delivery catheter balloon tip was still at the distal end of the dislodged stent.The balloon was partially inflated to retrieve the stent; however, during withdrawal, the 9mm stent caught the proximal portion of the implanted omnilink 7mm stent.The omnilink 7mm stent elongated.The omnilink 9mm sds with stent and terumo sheath were removed as a single unit.A new introducer sheath was inserted.A 7mm balloon was used to dilatate the implanted omnilink 7mm stent with acceptable results.The internal iliac lesion was left without further treatment.Endarterectomy was performed within the femoral vessel.The following day, on (b)(6) 2017, the external iliac artery occluded with thrombus.On (b)(6) 2017, another endarterectomy was performed in addition to "patch-plastic" of the femoral vessel.Another percutaneous intervention was performed, placing a non-abbott stent in the distal stent, and thrombectomy and stent implant was performed within the iliac vessels distal to the 7mm omnilink stent.Reportedly, the patient is in good condition.There was no additional information provided regarding this issue.

Manufacturer Narrative

(b)(4).The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported lot revealed no other incidents.It should be noted that the reported patient effect of stent thrombosis is listed in the omnilink elite peripheral stent system instructions for use (ifu) as a known potential adverse event.The investigation determined that the reported difficulties and subsequent patient effects are related to circumstances of the procedure.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 DELIVERY 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): CLONMEL, IRELAND REG# 9616693; 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: 6856388
• MDR Text Key: 85735616
• Report Number: 2024168-2017-07391
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 11/09/2017

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
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: 11003-59
• Device Lot Number: 7041041
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/17/2017
• Initial Date FDA Received: 09/11/2017
• Supplement Dates Manufacturer Received: 11/01/2017
• Supplement Dates FDA Received: 11/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2017
• 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