MAUDE Adverse Event Report: AV-TEMECULA-CT SUPERA SELF-EXPANDING STENT SYSTEM; SELF EXPANDING STENT SYSTEM

Catalog Number S-60-150-120-P6

Device Problems Difficult or Delayed Positioning (1157); Material Deformation (2976)

Patient Problems Cardiac Arrest (1762); Thrombosis (2100); Respiratory Failure (2484)

Event Date 10/27/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.The other supera device referenced is being filed under separate medwatch report.

Event Description

It was reported that after lesion pre-dilatation to 6 mm of the chronic totally occluded, heavily calcified, superficial femoral artery a 5.0 x120 supera was implanted in the popliteal without issue.A 6.0x150 supera stent was positioned and was being deployed in the distal sfa when the thumb slide turned without advancing the stent; after manipulation the stent was successfully fully deployed but had elongated.A 6.0 x150 supera stent was being deployed in the mid sfa and encountered the same difficulty but ultimately was successfully deployed with stent elongation.Post deployment fluoroscopy revealed thrombus at the ostium of the sfa which was aspirated and the patient was given tpa and left the catheterization lab.During the evening the patient coded and was intubated.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: visual inspections were performed on the returned device.The deployment difficulty and elongated stent was not able to be confirmed as the stent had already been deployed and remains in the patient.Potential factors for difficulty deploying the stent include, but are not limited to, manufacturing, anatomical conditions; deployment technique and/or damage to the device deployment mechanisms (handle components/shaft lumens/ratchet).Based on the reported information and analysis of the returned device, the deployment difficulty may be the result of anatomical conditions as the lesion site was described as heavily calcified.It may be possible that the distal sheath of the delivery system was bent or restricted within the anatomy such that the ratchet efficiency was compromised and the ratchet was unable to engage the stent properly; however, this could not be confirmed.The stent stretching likely occurred due to manipulation of the delivery system to ultimately release the stent.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 did not indicate a lot specific quality issue.The reported patient effect of thrombosis, as listed in the supera instructions for use is a known patient effect.The investigation was unable to determine a conclusive cause for the reported difficulties and patient effects.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.

• Brand Name: SUPERA 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 4628
• Manufacturer (Section G): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; 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: 6111813
• MDR Text Key: 60283563
• Report Number: 2024168-2016-08072
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P120020
• 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: 12/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Catalogue Number: S-60-150-120-P6
• Device Lot Number: 5100761
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/02/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2015
• 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
• Treatment: STENT: 5.0 X 120 SUPERA
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 52 YR
• Patient Weight: 88