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

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Pain (1994); Numbness (2415); Pseudoaneurysm (2605)

Event Date 01/01/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).It is indicated that the device is not returning for evaluation; therefore, a failure analysis of the complaint device could not be completed.Reviews of the lot history record and complaint history could not be conducted because the lot number was not provided.Based on the reviewed information, no product deficiency was identified.

Manufacturer Narrative

(b)(4).

Event Description

This event was captured based on review of the article, late presenting, contained rupture of the superficial femoral artery following atherectomy and stenting: case report and literature review by s.Clegg, a.Aghel, k.Rogers in catheterization and cardiovascular interventions, (b)(6) 2014.It was reported that the mid and distal superficial femoral artery (sfa) target lesion was treated with six passes of an excisional atherectomy catheter, but the results were suboptimal.The target lesion was aggressively predilated with a 6.0 mm fox sv balloon dilatation catheter at high pressure.The 6 mm supera stent was implanted with adequate results.Four days later, the patient reported a sudden onset of left leg pain in the inner thigh that progressed to severe pain and associated paresthesia involving the anteromedial aspect of the lower left leg.Pulses were palpable, but the thigh was tender to touch.Duplex ultrasound of the left lower extremity revealed a patent stent with no apparent pathology.At the one month routine follow-up visit, the patient continued to have left thigh discomfort and paresthesia below the knee.Duplex ultrasound of the left lower extremity revealed a patent stent in the sfa with a surrounding 3x2x2 anechoic area where there was pulsatile, low-velocity arterial flow.Fluoroscopy results suggested extravascular migration of the stent.Angiography revealed flow into a contained space at the site of the extravascular portion of the stent, consistent with a pseudoaneurysm.A non-abbott stent graft was deployed and successfully sealed the pseudoaneurysm.

Manufacturer Narrative

(b)(4).One month later, the left thigh discomfort and lower leg paresthesia had improved.The physician reported that he did not think the supera, nor the fox sv caused the event, but rather, it is a known complication of endovascular intervention precipitated in this patient by extreme vessel calcification, atherectomy, aggressive pre dilatation for a 6 mm supera stent.Concomitant products: atherectomy: turbohawk ls-c; embolic protection: 6.0 mm spider; balloon dilatation: fox sv.The stent remains in the patient.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The other device (fox sv) referenced is being filed under a separate medwatch mfr number.

• Brand Name: SUPERA PERIPHERAL 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): WEBSTER, TX USA REG#3005325609; abbott vascular; 26531 ynez rd.; temecula CA 92591 462
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 3703120
• MDR Text Key: 11763285
• Report Number: 2024168-2014-01819
• 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: Literature
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/27/2014

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2014
• Initial Date FDA Received: 03/27/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/03/2014; 11/21/2014
• 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: CONCOMITANT MEDICAL DEVICES
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR