MAUDE Adverse Event Report: MEDTRONIC MEXICO PACIFIC PLUS CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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

Patient Problem Pulmonary Edema (2020)

Event Date 04/09/2019

Event Type  Injury  

Manufacturer Narrative

Event date: date of article publication pulmonary artery stenting in a patient with takayasu¿s arteritis using a novel balloon-expandable covered stent sage open medical case reports (2019) (7)1-3 10. 1177/2050313x19841955. If information is provided in the future, a supplemental report will be issued.

Event Description

Patient with takayasu¿s arteritis was admitted with left sided pneumonia after a several year history of exertional dyspnea. A ct angiogram was obtained and revealed severe stenosis of the right main pulmonary artery (pa), resulting in marked reduction in blood flow to the right lung. Echocardiography demonstrated normal left ventricular (lv) function, moderate tricuspid regurgitation and estimated pa pressure of 62 mmhg. To minimize the risk of pa rupture, we planned to use a non-medtronic balloon-expandable covered stent as definitive treatment. Due to the risk of post-procedure pulmonary edema, the patient was electively intubated prior to the procedure. An 8fx90 cm non-medtronic sheath was advanced from the right common femoral vein to the main pa. A 7f non-medtronic coronary guide catheter was used for selective angiography and to advance a 0. 018 non-medtronic wire to the distal right pa. Systemic anticoagulation was achieved with intravenous heparin. The right pa was then studied with intravascular ultrasound imaging which confirmed severe stenosis of 96% due to fibrotic thickening of the vessel wall due primarily to thickening of the media. The pa diameter was measured at 14 mm. The stenosis was dilated using a 7 mm x 40 mm pacific plus angioplasty balloon and a 10 mm x 40 mm evercross angioplasty balloon. The result appeared sub-optimal with 60% residual stenosis and an irregular appearance to the luminal wall. Lesion length was estimated at 40 mm. The 0. 018¿ wire was exchanged for a 260 cm 0. 035¿ wire. The guide catheter and the 8fx90 cm sheath were exchanged for an 8f 45 cm sheath. An 11 mm x 59 mm non-medtronic stent was advanced to the stenosis and deployed. The stent was further dilated with a 14 mm x 60 mm non-medtronic angioplasty balloon which resulted in the expected foreshortening of the 59 mm stent to a final length of 42 mm. Final angiography revealed no residual stenosis with satisfactory stent position. As anticipated, the patient developed pulmonary edema post-procedurally which resolved in 48 h with aggressive diuresis allowing extubation. Systemic anticoagulation (for paroxysmal atrial fibrillation) was resumed with rivaroxaban 20 mg daily. Clopidogrel 75 mg daily was added and will be administered indefinitely for anti-platelet effect to minimize the risk of stent thrombosis. A repeat echocardiogram obtained 1 week after the procedure showed only minimal decrease in estimated pa pressure compared to baseline. Patient underwent a ct angiogram 3 months post-procedure which showed the pa stent to be widely patent with no evidence of restenosis and was stable without dyspnea at 6-month clinical follow-up.

• Brand Name: PACIFIC PLUS
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 8763704
• MDR Text Key: 150115640
• Report Number: 9612164-2019-02710
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123358
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial
• Report Date: 07/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/24/2019
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage

Patient Treatment Data

Date Received: 07/05/2019 Patient Sequence Number: 1