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

Catalog Number 1012623-19

Device Problems Difficult or Delayed Positioning (1157); Migration or Expulsion of Device (1395); Improper or Incorrect Procedure or Method (2017); Physical Resistance (2578); Device Damaged by Another Device (2915); Material Deformation (2976)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Embolism (1829)

Event Date 06/29/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.A significant delay occurred, but did not cause or contribute to a health impact.No additional information was provided.(b)(4).Concomitant medical product: dilatation catheter: 8.0mmx20mmx80cm armada 35, guide wire: terumo glide advantage.The stent remains in the patient and the customer reported that the delivery system was discarded.Investigation is not yet complete.A follow up report will be submitted with all relevant information.The 8.0mmx20mmx80cm armada 35 referenced is being filed under a separate manufacturing report number.

Event Description

It was reported that the procedure was to treat a heavily calcified lesion in the totally occluded ostial subclavian artery.An unspecified guide wire was advanced without issue.The lesion was pre-dilated using a 5.0x20 armada balloon.A 7.0mmx19mmx 80cm omnilink elite otw balloon expandable stent system was advanced via left brachial access to the lesion with difficulty due to heavy calcification; no unusual force was applied.The omnilink stent was deployed at nominal pressure, but was not fully apposed to the vessel wall.Thus, an 8.0mmx20mmx80cm armada 35 balloon was advanced to the stent.Post-dilatation was performed, resulting in collapsed stent struts for the omnilink stent.The 8.0x20 armada 35 balloon was withdrawn from the stent with slight difficulty due to becoming caught on the stent struts, but was ultimately withdrawn.The guide wire was exchanged for a non-abbott guide wire; when advancing the new non-abbott wire, the stent loosened / shifted slightly from its implant site, but was still within the diseased target area.The 8.0x20 armada 35 was re-advanced with difficulty due to the balloon getting caught on the stent struts, and additional stent post-dilatation was performed.When attempting to withdraw the armada 35 again, the balloon became caught on the stent struts and the omnilink elite stent was explanted, migrated into the aorta and down to the left external iliac artery.The migrated stent was crushed against the iliac vessel wall via balloon angioplasty then a stent was deployed, securing the crushed omnilink elite stent.The subclavian lesion was ultimately treated via balloon angioplasty with no attempt to deploy another stent.There were no adverse patient sequelae.

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 was reported that the procedure was to treat a heavily calcified lesion in the totally occluded ostial subclavian artery.It should be noted that the otw omnilink elite instructions for use (ifu) states: the omnilink elite stent system is indicated for the treatment of atherosclerotic iliac artery lesions with reference vessel diameters of greater than 5.0 mm and less than 11.0 mm, and lesion lengths up to 50 mm.In this case, it could not be determined if using the omnilink elite off-label caused or contributed to the reported difficulties.Embolization is listed in the otw omnilink elite instructions for use as a known potential adverse event associated with percutaneous iliac artery treatment, including the use of an iliac stent.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 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: 6736186
• MDR Text Key: 80805421
• Report Number: 2024168-2017-06151
• 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,Followup
• Report Date: 10/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Catalogue Number: 1012623-19
• Device Lot Number: 6120241
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2016
• 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; Disability
• Patient Age: 63 YR