MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ISLEEVE; INTRODUCER, CATHETER

Device Problem Failure to Advance (2524)

Patient Problem Vascular Dissection (3160)

Event Date 03/14/2022

Event Type  Injury  

Event Description

Accurate ide study.It was reported that a vessel dissection occurred.Prior to the index procedure, heparin or other anticoagulant was given.At the time of event, the subject was on aspirin and ticagrelor.The subject was on a prior regimen of aspirin and antiplatelet other than aspirin at the time of index procedure.On (b)(6) 2022, the subject received loading dose of 81 mg of aspirin prior to the procedure.A 14f isleeve introducer sheath was placed.The native aortic valve was treated with balloon valvuloplasty and subsequent deployment of a small size accurate neo2 aortic valve.Post dilatation was not performed.Post balloon valvuloplasty, the subject was noted with left bundle branch block (lbbb).There was correct positioning of a single prosthetic valve in the correct anatomical location.Post deployment of the size small accurate neo2 valve, while removing the 14f isleeve sheath, angiography was performed which revealed a dissection in the distal abdominal aorta and another dissection in the right external iliac artery (eia) and right common iliac artery (cia) extending down into the external iliac artery.Due to the dissection, significant luminal compression was noted.A balloon inflation was performed however there was significant balloon compression of the dissection.A 8 x 80 non-boston scientific (bsc) self-expanding stent was placed.Angiography revealed good repair however there was no distal runoff into the groin.After multiple attempts made at wiring the true lumen, it was decided to open the right groin.The right groin was opened and post achieving the proximal and distal control using the clamp, the vessel was opened which revealed significant amount of intima that was intussuscepting down the middle of the artery and extruding into the common femoral artery.The subject underwent an open repair of the right common femoral artery by performing endarterectomy to remove all the extruded intima.The clamp was released, and vigorous proximal flow was noted.Once endarterectomy was completed, there was still a small flap proximally that needed to be tacked down.After tacking down, dissection site appeared good with back bleeding and antegrade flow.Patch angioplasty was performed with a bovine pericardial patch.Several de-airing maneuvers was performed and finally clamps were removed.The subject was given half dose of protamine for reversal.The wounds were all cleaned and dried.Sterile bandage was placed.Doppler showed good distal pulses and signal in both feet at the end of procedure.Echocardiogram was performed at the end of procedure which showed good result.Non-bsc closure device induced acute closure of the vessel was noted.Attempts were made to reopen the artery using a contralateral approach by advancing the catheter from the left femoral artery and a non-bsc guidewire across the lesion, however the non-bsc guidewire could not cross the occluded lesion.The cutdown of right femoral artery was performed successfully.The subject was also noted with acute blood loss with 300 ml blood loss which was procedure related from repair of femoral artery.The subject was also noted with acute blood loss anemia secondary to procedure related.The subject was transferred to post anesthesia care unit where the subject was sleepy but arousable and hemodynamically stable.The subject was noted with uti (urinary tract infection) (present on admission) and leukocytosis and had elevated troponin.The subject was recommended to continue on macrobid for uti for 5 days.Chest x-ray revealed no acute cardiopulmonary process.On (b)(6) 2022, the subject complained of right lower quadrant pain above incision in the lower abdomen with pop superficially and had urinary incontinence.The subject denied shortness of breath and chest pain.The subject was ordered tylenol and oxycodone if needed and recommended to take home dose of oxybutynin.On the same day, on evaluation of right femoral access site, the subject was noted with mild edema and ecchymosis.Left femoral access site was without swelling or hematoma and distal pulse were palpable.The subject was recommended for computerized tomography (ct) of the abdomen and pelvis for abdominal pain and also recommended for echocardiogram today and increases ambulation.On the same day, ct abdomen and pelvis without contrast revealed, small renal calculi, cyst present in anterior left kidney measuring 4.2 x 4.6, trace bilateral effusions, subcutaneous gas and stranding in the right inguinal region with mild fluid adjacent to surgical clips associated with right femoral vessels.No retroperitoneal hemorrhage was noted.Post procedure/discharge transthoracic echocardiogram performed on (b)(6) 2022, revealed small accurate valve in position with mild to moderate aortic regurgitation, the aortic valve area of 1.5 cm^2.The mean aortic pressure gradient was 14 mmhg with left ventricular ejection fraction of 75%.Mild aortic regurgitation was noted.On the same day, laboratory investigation revealed hemoglobin of 8.9 g/dl (11.7-15.5 g/dl) and hematocrit of 26.7% (35.0-46.0%).On (b)(6) 2022, the subject continued to experience right lower abdominal pain just above the vacuum-assisted wound closure (vac) site and right flank area.The subject had taken pain medication previous night which alleviated the pain and the subject slept well overnight.On examination, right leg had good distal pulse, foot was warm, and pink, and denied any numbness and tingling.Ct with no evidence of bleeding into the rectus muscle.The abdominal discomfort was suspected to be related to nerve pain and the subject was started low dose neurontin.On the same day, hemoglobin appeared to be drifting downward to 8.7 g/dl (11.7-15.5 g/dl) likely due to right common femoral artery (cfa) dissection s/p repair.Vitals were normal.On the same day, electrocardiogram (ekg) showed normal sinus rhythm with incomplete lbbb and heart rate of 64 beats per minute.The subject was encouraged to take pain medication when needed, given miralax for bowel movement, recommended to continue provena wound vac.On (b)(6) 2022, the subject stated that the pain was much improved and was sitting up feeling well.Physical exam showed normal lower extremities, atraumatic with no cyanosis or edema and left groin was soft and right groin with intact provena wound vac.The pulses were 1+ and symmetric, lung was clear to auscultation bilaterally and chest wall with no tenderness.The subject did report dizziness when standing up which was suspected to be related to neurontin medication.The subjects blood pressure was at the border line and hence, labetalol was reduced to 150 mg bid.On (b)(6) 2022, laboratory investigation revealed lowest hemoglobin associated with the event: 8.0 g/dl (reference range: 11.7-15.5 g/dl), lowest hematocrit associated with the event: 24.4% (reference range: 40.0 to 49.0 %).At the time of reporting events of right iliofemoral dissection and distal abdominal aorta dissection) were considered ongoing.On (b)(6) 2022, the subject was discharged on aspirin and ticagrelor.

• Brand Name: ISLEEVE
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15695903
• MDR Text Key: 302684219
• Report Number: 2124215-2022-44270
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2022
• 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: 10/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White