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

Catalog Number 1012633-19

Device Problems Break (1069); Improper or Incorrect Procedure or Method (2017); Device Damaged by Another Device (2915); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/20/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Concomitant medical products: dilatation catheter: 10 x 20 mm armada.(b)(4).The customer reported the device was discarded.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The armada referenced is being filed under a separate medwatch mfr number.

Event Description

It was reported that the procedure was to treat a moderately tortuous and moderately calcified left subclavian artery.A 10 x 19 mm omnilink elite stent was deployed without issue.A 10 x 20 mm armada balloon catheter was inflated to 13 atmospheres for post-dilatation.There was no resistance during post-dilatation.Angiography revealed the implanted stent appeared to be fractured and some of the struts were stretched.Post-dilatation was again performed with a non-abbott balloon catheter to complete the procedure.There was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).It is indicated that the device is not returning for evaluation; therefore, a failure analysis of the complaint device could not be completed.A review of the complaint history identified no similar incidents from this lot.Based on the reported information, there is no indication of a product quality issue with respect to manufacture, design, or labeling.The investigation determined that the reported stent damage appears to be due to operational context.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.It was reported that the omnilink elite was used to treat the subclavian.It should be known that the otw omnilink elite instructions for use indications section, 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.Based on the reviewed information, there is no indication the issue was caused by, or related to the design, manufacture or labeling of the device.

Manufacturer Narrative

(b)(4).

• 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: 5002018
• MDR Text Key: 22942828
• Report Number: 2024168-2015-04637
• 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: Followup,Followup
• Report Date: 12/22/2015

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
• Device Expiration Date: 08/31/2018
• Device Catalogue Number: 1012633-19
• Device Lot Number: 5030941
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/13/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 09/15/2015; 12/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2015
• 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
• Patient Age: 71 YR
• Patient Weight: 60