MAUDE Adverse Event Report: MEDTRONIC MEXICO AMPHIRION DEEP PTA BALLOON CATHETER; CATHETER, PERCUTANEOUS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Reocclusion (1985)

Event Date 05/05/2017

Event Type  Injury  

Manufacturer Narrative

Event date is literature article published date.Severe mesenteric ischemia in a pregnant woman with antiphospholipid syndrome annals of vascular surgery (2017) volume 44, pages 415.E11-415.E16 doi.Org/10.1016/j.Avsg.2017.04.035 if information is provided in the future, a supplemental report will be issued.

Event Description

Patient is smoker, at 20th week of pregnancy was referred in emergency for thoracic and abdominal sudden pain.She was affected by aps with positive to apl antibodies (both acl and la) and chronically assumed warfarin as anticoagulant therapy.The patient had recurrent pregnancy complications: spontaneous abortion at 6 weeks and premature stillbirth at 24 and 27 weeks with 1 episode of preeclampsia.Her past medical history was remarkable for deep venous thrombosis of the right lower limb and chronic mesenteric ischemia due to occlusion of the celiac trunk and the superior mesenteric artery (sma), for which the patient had already been submitted 1 year earlier to an unsuccessful attempt of sma endovascular revascularization.The patient presented with abdominal tenderness associated with mild distension.Duplex scan was highly suspicious for inferior mesenteric artery (ima) occlusion.After obstetric consultation, in order to proceed with more invasive exams and intervention, the patient underwent therapeutic abortion of the fetus using mifepristone.Computed tomography angiography (cta) was performed showing the complete occlusion of ima without evident signs of colic suffering.Through a transperitoneal surgical approach, the ima was exposed, and thrombectomy with a 4f non-medtronic catheter was performed.At the end of the procedure, there were both a good inflow and backflow in the artery without clinical signs of intestinal ischemia.3 days post thromectomy of the inferior mesenteric artery (ima) with the non-mdt catheter, reocclusion occurred.Endoluminal thrombectomy with export aspiration catheter was performed.On completion of angiogram, a residual ostial stenosis was observed, and therefore, an angioplasty with amphirion 3.5x40mmballoon was realized.After 3 weeks, the patient was referred again to the emergency room for sudden and acute abdominal pain.An urgent cta showed a complete occlusion of the ima.It is reported that the surgical and endovascular thrombectomy were ineffective to obtain durable ima patency.Therefore through a redotransperitoneal surgical approach an anterograde aortamesenteric bypass graft using a reversed saphenous vein was performed, followed by the resection of anileal loop.The patient was discharged after 15 days from surgery without postoperative complications and symptom free.A double antiplatelet and anticoagulant therapy, with an international normalized ratio over 3, was again administered for prevention of restenosis and new thrombotic events.During follow-up, the patient did not refer any symptom, and a cta performed 6 months after surgery revealed good patency of the aorta-mesenteric bypass.

Manufacturer Narrative

Additional information: the corresponding author confirmed there was no issue with a medtronic device.If information is provided in the future, a supplemental report will be issued.

• Brand Name: AMPHIRION DEEP PTA BALLOON CATHETER
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC MEXICO; avenida paseo del cucapah #105; parque industrial el lago; tijuana, b.c.,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; avenida paseo del cucapah #105; parque industrial el lago; tijuana, b.c.,bc 22570 ; MX 22570
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 7120749
• MDR Text Key: 94961774
• Report Number: 9612164-2017-01968
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K052791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2017
• 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
• Date Manufacturer Received: 11/15/2017
• 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): Required Intervention
• Patient Age: 34 YR