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

Catalog Number S-65-060-120-P6

Device Problems Detachment Of Device Component (1104); Migration or Expulsion of Device (1395); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/10/2015

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).The device was received.The investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that a 7.0 armada balloon catheter was used to pre-dilate a lesion with mild tortuosity and mild calcification in the left common femoral artery.A supera self-expanding stent system (sess) was advanced toward the target lesion; an attempt was made to deploy the stent, but the thumb slide was not fully retracted to the starting position.Additionally, the system lock and the deployment lock were not rotated into the locked position.It was believed that the stent was deployed; however, during removal of the sess it was noted that the stent migrated back from the intended implant site.The tip of the sess was also noted to have broken off inside the patient anatomy.A second supera sess was opened, but not used, in order to look at the device and better understand how the device would look under fluoroscope.There was a clinically significant delay in the procedure.Ultimately the patient was sent to surgery for a cut down and the sheath was removed with the tip and stent fully intact.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: (b)(4).User facility (voluntary) medwatch report received: medwatch report number was not provided.The cine of the event was received and reviewed by an abbott clinical specialist who concluded the following: based on the imaging provided, the intended deployment site, while reported as the common femoral artery, appears to be the distal external iliac artery.According to the indications listed in the instructions for use (ifu) the supera peripheral stent system is indicated for use in the treatment of the sfa and / or proximal popliteal arteries.As such the device appears to have been deployed in an off-label vessel.Additionally, the deployment process may not have been completed in a manner consistent with the ifu recommendations with regards to the unlocking of both the system lock and the deployment lock prior to initiating the deployment process.While delivery is possible when this is done, controlled deployment is significantly compromised.Based on the images provided, it appears that the deployment process was not continued after the first throw or slide of the thumb slide.Additionally, the vessel diameter appeared to be larger than the maximum stent diameter of 6.5 mm.The ifu advises against oversizing, or post dilating, the stent by more than 1.0 mm.In this case the vessel was prepared to a diameter of 7.0 mm which is 0.05 mm larger than the nominal deployed outer diameter of the stent.As it appeared in the images, the stent, upon initial deployment, was able to move freely which implies that there was little, if any, vessel wall opposition.The device was returned and the reported tip separation was confirmed.The stent migration could not be confirmed as it was based on case circumstances.Based on a visual inspection of the returned product, there is no indication of a product quality issue with respect to manufacture, design, or labeling.The investigation determined that, the reported tip detachment appears to be user related.The stent migration, surgical procedure, delay in procedure and hospitalization are due to operational context.A review of the lot history record identified no manufacturing nonconformities.Additionally, a review of the complaint history identified no similar incidents from this lot.It should be noted that the supera ifu instructs: following confirmed implantation of the supera stent, retract the thumb slide in a single motion to the starting position on the handle and rotate the system lock and deployment lock into the locked position, in line with the thumb slide.Based on the information reviewed, there is no indication the issue was caused by, or related to the design, manufacture or labeling of the device.

Event Description

User facility medwatch received which states: patient for lower extremity peripheral intervention.Delivery system broke off and the stent partially deployed, unable to be removed from artery.Required surgical intervention right femoral artery was cutdown with exploration and removal of stent delivery system and sheath.Icu post-operative stay.The patient was discharged two days after the procedure.

• 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): WEBSTER, TX USA REG#3005325609; abbott vascular; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 5052314
• MDR Text Key: 24883908
• Report Number: 2024168-2015-05068
• 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
• Report Date: 09/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2016
• Device Catalogue Number: S-65-060-120-P6
• Device Lot Number: 02390066
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/25/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2014
• 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): Hospitalization; Required Intervention
• Patient Age: 69 YR