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); Stretched (1601); Inadequate or Insufficient Training (1643); Improper or Incorrect Procedure or Method (2017); Difficult or Delayed Activation (2577); Patient-Device Incompatibility (2682); Material Deformation (2976)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/26/2018

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).The product was not returned to abbott vascular for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents reported from this lot.It should be noted that the supera peripheral stent system electronic instructions for use (ifu) states: the supera peripheral stent system should only be used by physicians and medical personnel trained in vascular interventional techniques and trained on the use of this device.The investigation determined the reported difficulty to deploy the stent appears to be related to user error as the physician was not familiar with the supera device and had not received proper training.The reported stent elongation/stretching appear to be related to operational circumstances of the procedure as it is likely that handling and manipulation during the attempts to deploy the stent resulted in the stent to deploy and stretch out side of the intended site.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

It was reported that this was a percutaneous intervention in the proximal superficial femoral (sfa) to popliteal arteries to treat in-stent restenosis with vessel occlusion.During wiring attempts, the distal sfa perforated and was treated with covered stent.The physician was unable to access the vessel's true lumen.Pre-dilatation was performed with a 6.0 balloon and a supera stent delivery system (sds) was advanced within the sub-intimal plane to the lesion site.Reportedly, the physician was not familiar with the supera stent and had not received training for this device.Stent deployment was performed at the sfa.During attempts of stent delivery system release, the supera stent stretched.The stent was released from the delivery system and had stretched from above the sfa and into the common femoral artery, an unintended site.The stent was completely outside the intended area and was not apposed to the common femoral artery vessel.Reportedly, there was no treatment performed.No additional information was provided regarding this issue.

Manufacturer Narrative

(b)(4).

• 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: 7797535
• MDR Text Key: 117601383
• Report Number: 2024168-2018-06371
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648211843
• UDI-Public: 08717648211843
• 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: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/20/2018

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: 07/31/2019
• Device Catalogue Number: S-60-150-120-P6
• Device Lot Number: 7082261
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/20/2018
• Initial Date FDA Received: 08/20/2018
• Supplement Dates Manufacturer Received: 08/20/2018
• Supplement Dates FDA Received: 08/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2017
• 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): Other
• Patient Age: 70 YR
• Patient Weight: 95