MAUDE Adverse Event Report: AV-TEMECULA-CT ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM; SELF EXPANDING STENT SYSTEM

Catalog Number 1012534-40

Device Problems Detachment Of Device Component (1104); Difficult or Delayed Positioning (1157); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/24/2014

Event Type  Injury  

Event Description

It was reported that during a procedure to treat a calcified superficial femoral artery (sfa), pre-dilatation was performed.A 6x40 mm absolute pro vascular self-expanding stent system (sess) was advanced without resistance to the lesion and during stent deployment, the stent began overlapping and folding over on itself.The stent was deployed in the lesion; however, the stent was compressed and not fully apposed.The sess was withdrawn from the patient anatomy without resistance.Another absolute pro sess was advanced and deployed inside of the previously implanted stent to fully appose the stent to the vessel wall and cover the entire length of the lesion.There was no adverse patient effect and no clinically significant delay in the procedure.Return device analysis revealed that the tip and distal outer sheath were separated and not returned.Additional reported information indicates that the stent was difficult to deploy and force was applied to deploy the stent.The distal outer sheath and the tip separated inside the patient in the sfa.A snare device was used to retrieve everything from the patient anatomy, the separated distal outer sheath and the tip.The procedure was completed successfully and the patient is doing well.No additional information was provided.

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Evaluation summary: the device was returned for analysis and the difficulties deploying the stent was not confirmed.The sheath and tip separations were confirmed.The inaccurate delivery could not be replicated as the stent had already been deployed.Based on a visual and functional inspection, 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 incidents reported for difficult to deploy, inaccurate delivery, or sheath/tip separation for this lot.Based on the reviewed information, no product deficiency was identified.

• Brand Name: ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM
• Type of Device: SELF EXPANDING STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 462
• Manufacturer (Section G): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; 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: 4347071
• MDR Text Key: 5137877
• Report Number: 2024168-2014-08309
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110028
• 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
• Report Date: 11/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2017
• Device Catalogue Number: 1012534-40
• Device Lot Number: 4091961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2014
• 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
• Patient Outcome(s): Required Intervention