MAUDE Adverse Event Report: COVIDIEN EVERFLEX SELF-EXPANDING PERIPHERAL STENT WITH ENTRUST DELIVERY SYSTEM STANDARD; STENT, SUPERFICIAL FEMORAL ARTERY

Device Problems Device Sensing Problem (2917); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Perforation (2001); Atrial Perforation (2511); Pseudoaneurysm (2605)

Event Date 04/12/2018

Event Type  Injury  

Manufacturer Narrative

Event date estmate = literature article published date.Implant date estimate = literature article published date.Doi: 10.1177/1544316718763392 the role of duplex ultrasound in the detection of upper extremity artery pathology, and post endovascular complications journal for vascular ultrasound 2018 vol.42(1) 26¿29.If information is provided in the future, a supplemental report will be issued.

Event Description

Case study: the role of duplex ultrasound in the detection of upper extremity artery pathology, and post endovascular complications abstract: upper extremity pathology is uncommon and generally involves the brachial artery in about 12% of the cases.Of chronic upper limb ischemia, trauma, fibromuscular dysplasia, giant cell arteritis, and atherosclerosis are among the most reported cases.After a thorough review of the literature, there is agreement with duplex ultrasound sensitivity and specificity for predicting >70% stenosis in the subclavian arteries with a sensitivity of >82% and specificity of >90%.This article not only correlates the relationship between duplex ultrasound and severe peripheral arterial disease, but it also proves with 100% accuracy the ability to detect latent and abnormal pathology of the upper extremities post endovascular intervention.Event description: a patient was brought to the angiography suite to treat a chronic total occulsion(cto) in the right subclavian artery.Once the subclavian artery lesion was crossed, high pressure balloon angioplasty and stenting using a 8 mm × 50 mm non-mdt covered stent graft was performed.The distal portion of the covered stent edge was slightly oversized, and crowned; therefore, an 8 mm × 40 mm everflex self-expanding stent was deployed to smooth out the flow.At this point, completion angiogram was performed with no evidence of dissection, thrombus, side branch loss, or perforation.The patient returned to the facility 2 days later with complaints of radiating right arm and brachial access site pain.An ultrasound was performed and it was immediately noted that one of 2 brachial veins at the access site were arterialized by doppler, along with significant localized color doppler bruit.It was reported there was an abnormal communication between the brachial artery and vein; attention was then turned to the subclavian artery¿s previous intervention.It was determined by duplex imaging that the subclavian stents and native subclavian artery were patent with turbulence in the doppler signals.There appeared to be an anechoic area posterior to the stent with color doppler swirl pattern indicative of active arterial complication.A posterior stent active pseudoaneurysm/perforation was present with a contained sac measuring 1.8 cm × 1.5 cm.Angiography was performed at the level of distal subclavian/axillary artery area, and an active bleed was noted at the level of the subclavian self-expanding distal stent edge.The brachial artery to brachial vein communication was confirmed so it was felt medical management was warranted.The active bleed was at the level of the previously deployed distal subclavian stent edge/prox native axillary artery.An 8 mm × 50 mm non-mdt stent was placed overlapping the previously deployed everflex self-expanding stent.The non-mdt stent was then post dilated with a 7 mm × 4 mm non-mdt balloon.Finally, completion angiogram of the right subclavian and axillary arteries was performed with no evidence of complication and successful repair of right axillary artery perforation with a non-mdt stent graft.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: EVERFLEX SELF-EXPANDING PERIPHERAL STENT WITH ENTRUST DELIVERY SYSTEM STANDARD
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): COVIDIEN; 4600 n nathan lane; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 n nathan lane; plymouth MN 55442
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 7722791
• MDR Text Key: 115207222
• Report Number: 2183870-2018-00397
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/04/2018

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/13/2018
• Initial Date FDA Received: 07/26/2018
• Supplement Dates Manufacturer Received: 08/08/2018
• Supplement Dates FDA Received: 10/04/2018
• 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): Required Intervention
• Patient Age: 43 YR