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

Device Problems Material Separation (1562); Material Deformation (2976)

Patient Problems Pain (1994); Swelling (2091); Claudication (2550); Pseudoaneurysm (2605)

Event Date 10/09/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date of implant has been estimated.The stent remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.Article titled: endovascular treatment of simultaneous iliac and superficial femoral arterial pseudoaneurysms after stenting procedure complications (b)(4).

Event Description

It was reported through a presentation titled: 'endovascular treatment of simultaneous iliac and superficial femoral arterial pseudoaneurysms after stenting procedure complications" that the procedure was to treat a pseudoaneurysm of the left common iliac artery (lcia).The patient had a significant history of peripheral vascular disease.Post-stenting of a supera stent, the patient was re-hospitalized due to severe claudication, back pain and right groin region swelling.A computed tomography was performed and a lcia pseudoaneurysm was noted with embedded supera stent fragments.It was then determined that the supera stent was broken into two pieces in a intussusception form (overlapping each other) which caused the pseudoaneurysm to form.Additionally, the stent implant was also noted as kinked.An initial attempt was made to recanalize the fractured stent by a pull-through technique.A non-abbott catheter was advanced to catheterize the true lumen of the fractured stent and a 0.035 unspecified guide wire (gw) was advanced through the stent strut remnants, then the tip of the gw was captured via snare to assist in re-positioning the stent.An unspecified gw was then advanced after numerous attempts.A 9x59mm non-abbott covered stent was deployed within the supera stent, in a stent-in-stent technique.The pseudoaneurysm was successfully treated and there was no further leakage.After the procedure, medication was provided for treatment.A month after the procedure, follow-up showed distal restored flow without leakage.Six months later, the physician confirmed that the patient died from a mycotic infection of a non-abbott catheter.No additional information was provided.

Manufacturer Narrative

Internal file number - (b)(4).The udi is unknown because the part number and lot number were not provided.The device was not returned for analysis.The lot history record (lhr) for this product could not be reviewed and a similar incident query could not be performed because the product was not returned for evaluation and the part and lot numbers were not reported.The reported patient effects of pain, claudication, and pseudoaneurysm are known potential patient effects associated with the use of the device as listed in the supera instructions for use (ifu).The investigation was unable to determine a cause for the reported stent fracture and subsequent patient effects.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: 8038873
• MDR Text Key: 126156933
• Report Number: 2024168-2018-08458
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: CATHETER: TESIO
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 77 YR