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

Catalog Number 1012623-19

Device Problems Migration or Expulsion of Device (1395); Improper or Incorrect Procedure or Method (2017); Device Damaged by Another Device (2915)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/28/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(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.The investigation determined the reported difficulties and treatment appear to be due to operational context and no conclusive cause can be determined for the reported patient effect.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no similar incidents from this lot.It should be noted that the omnilink elite instruction for use states: pre-dilate the lesion or stricture with an appropriate size balloon dilatation catheter to closely match the lumen diameter proximal and distal to the lesion or stricture.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.The 8x20 armada 35 referenced is being filed under a separate medwatch mfr number.

Event Description

It was reported that the procedure was to treat a lesion in the heavily tortuous right iliac artery.The access site was the left femoral and access was also available from the right femoral.A 7.0x19mm omnilink elite stent delivery system (sds) was advanced to the lesion without pre-dilatation.The stent was successfully deployed and the balloon of the sds was inflated to 14 atmospheres twice to expand the stent.Angiography confirmed the stent was fully apposed.An armada 35 percutaneous transluminal angioplasty (pta) catheter was advanced.While it cannot be confirmed that the armada 35 pta catheter made contact with the 7.0x19mm omnilink elite stent, the 7.0x19mm omnilink elite stent migrated while the armada 35 pta catheter was in the patient anatomy.The 7.0x19mm omnilink elite stent migrated into the aorta, where it was hooked by an unspecified guide wire and pulled most of the way back into the iliac.However, before the stent could be deployed in the iliac, the stent moved back into the aorta where it was hooked by an unspecified guide wire that had access from the left femoral artery.The stent was repositioned into the left iliac with the guide wire, where it remains in healthy tissue.Post dilatation was not performed, but the 7.0x19mm omnilink elite stent appeared to be fully apposed to the vessel wall.A 9.0x19mm omnilink elite stent delivery system was used to successfully treat the lesion in the right iliac.There was no adverse patient sequela and no 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): 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: 5090837
• MDR Text Key: 26277444
• Report Number: 2024168-2015-05451
• 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
• Report Date: 09/20/2015

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: 07/31/2017
• Device Catalogue Number: 1012623-19
• Device Lot Number: 4021141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2014
• 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
• Treatment: BALLOON DILATATION CATHETER: ARMADA 35
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Weight: 72