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

Catalog Number 1012626-29

Device Problems Difficult or Delayed Positioning (1157); Loose or Intermittent Connection (1371); Migration or Expulsion of Device (1395); Device Damaged by Another Device (2915)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/14/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for analysis.The reported loose connection was not able to be confirmed.The reported difficulty deploying and difficult to position could not be replicated in a lab environment as it was based on case circumstances.Based on a visual and functional analysis of the returned device, there is no indication of a product deficiency.A review of the lot history record revealed no non-conformances that would have contributed to the reported event.A query of the electronic complaint handling database revealed no other similar incidents reported from this lot.Based on the reviewed information, no product deficiency was identified.

Event Description

It was reported that the procedure was to treat a proximal lesion in the left iliac artery with heavy calcification and mild tortuosity.The omnilink elite stent delivery system (sds) was advanced without issue and inflated to nominal pressure.The sds was pulled back some to take a check shot.It was noted that the stent was under-deployed; therefore, the sds balloon was to be used for additional dilatation.When the inflation device was attempted to be connected, it continued to pop off.The sds was removed and the armada balloon catheter was advanced, but could not cross the under-deployed stent.The sheath was positioned more distally for support, but the stent migrated to the aorta due to the interaction with the balloon catheter.The same inflation device was used with a 10 x 20 x 80 armada balloon to try to pull the stent into the iliac artery, but the balloon was not big enough for the vessel.An aortic balloon was then attempted, but unsuccessful.A snare device was used to pull the stent back to the access site, but the stent could not be retrieved further.The patient was sent to surgery.After surgery, it was noted that the stent was not located.The snare was also searched, but the stent was not found.The patient is now in icu.No additional information was provided.

Manufacturer Narrative

(b)(4).Concomitant products: dilatation catheter: 10 x 20 x 80 armada 35; guide wire: versacore floppy; inflation: intellisystem; sheath: 7f turumo; other: 20 x 40 atlas aortic balloon.The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.The armada referenced in b5 and d11 is being filed under a separate medwatch report.

• 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: 3793482
• MDR Text Key: 15790377
• Report Number: 2024168-2014-02843
• 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: 04/15/2014

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: 05/31/2016
• Device Catalogue Number: 1012626-29
• Device Lot Number: 3120441
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/24/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/13/2014
• Initial Date FDA Received: 05/06/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/16/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2013
• 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: 60 YR
• Patient Weight: 55