MAUDE MDR 2338078

MDR report key
2338078
Report number
2182269-2011-00175
Event key
0
Event type
3
Date received
2011-11-10
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
DENISE JOHNSON, RN
Address
14901 DEVEAU PL. MINNETONKA MN 55345 US
Phone
925-925-9259
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ANGIO-SEAL DEVICEANGIO-SEAL DEVICEST. JUDE MEDICALMGBNAUNKUNKR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12011-11-1001. H; 2. R

Event Narratives#

D

Patient 1

THE FOLLOWING WAS REPORTED VIA A LITERATURE ARTICLE IN THE ANNALS OF VASCULAR SURGERY JOURNAL, ISSUED 2011; VOLUME 25: 1078-1093. A (B)(6) MAN WITH A MEDICAL HISTORY OF ARTERIAL HYPERTENSION, DYSLIPIDEMIA, TOBACCO ADDICTION, AND CORONARY HEART DISEASE (LEFT VENTRICULAR EJECTION FRACTION AT 58%), AND WHO HAD ALREADY UNDERGONE AN ANGIOPLASTY WITH STENTING OF THE ANTERIOR INTERVENTRICULAR ARTERY (AIVA), WAS ADMITTED. HIS HOME TREATMENT CONSISTED OF A BETA-BLOCKER IN ASSOCIATION WITH A STATIN AND ASPIRIN. THE PT HAD ALREADY BEEN HOSPITALIZED IN A CARDIOLOGY INTENSIVE CARE UNIT FOR AN AURICULAR FLUTTER WITH VENTRICULAR TACHYCARDIA RESULTING IN A FAINTING FIT. A CORONAROGRAPHY WAS PERFORMED ON DAY 15 AS PART OF HIS CARDIOLOGICAL CHECKUP. IT SHOWED A TIGHT AIVA STENOSIS THAT WAS RESTENTED. THE PROCEDURE WAS CARRIED OUT USING A RIGHT INGUINAL APPROACH AND A 6-F INTRODUCER THAT ENDED WITH THE DEPLOYMENT OF A 6-F ANGIO-SEAL). A FEW HOURS AFTER THE PROCEDURE, THE PT PRESENTED WITH A RIGHT LOWER LIMB ISCHEMIA. CLINICAL EXAMINATION REVEALED RIGHT ILIAC ARTERY OBLITERATION. AT THE RIGHT LOWER LIMB, THE SYSTOLIC BLOOD PRESSURE INDEX (SPI) WAS 0.4. AN EMERGENT ARTERIOGRAPHY SHOWED A TIGHT STENOSIS OF THE ILIAC ARTERY ALONG WITH SUPERFICIAL FEMORAL ARTERY OBLITERATION AT ITS ORIGIN WITH A REINJECTION OF THE ABOVE-THE-KNEE POPLITEAL ARTERY AND OF THE TIBIAL ARTERIES. ON THE LEFT SIDE, THE PT WAS ASYMPTOMATIC, DESPITE MANY ATHEROMATOUS LESIONS. THE PT WAS INITIALLY MEDICALLY TREATED WITH HEPARIN AND VASODILATOR DRUGS, WHICH REDUCED THE ISCHEMIC SYNDROME. HOWEVER, 10 DAYS LATER, HE HAD TO BE OPERATED ON FOR A TIGHT INTERMITTENT CLAUDICATION OF THE RIGHT LOWER LIMB. THROUGH A RIGHT INGUINAL APPROACH, THE ANGIO-SEAL WAS WITHDRAWN FROM THE SUPERFICIAL FEMORAL ARTERY AND BALLOON ANGIOPLASTY OF THE RIGHT EXTERNAL ILIAC STENOSIS WAS PERFORMED. THE FEMORAL TRIPOD WAS RECONSTRUCTED WITH CLOSURE ON A PROSTHETIC PATCH. (B)(4).

N

Patient 1

NO PRODUCT WAS RETURNED. A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS UNAVAILABLE. BASED ON THE INFO RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. THE ANGIO-SEAL DEVICE INSTRUCTION FOR USE (IFU) CAUTIONS, SHOULD ISCHEMIC SYMPTOMS APPEAR, TREATMENT OPTIONS INCLUDE THROMBOLYSIS, PERCUTANEOUS EXTRACTION OF THE ANCHOR OR FRAGMENTS, OR SURGICAL INTERVENTION. THE ANGIO-SEAL DEVICE INSTRUCTIONS FOR USE (IFU) INSTRUCTS THE USER TO ASSESS THE PUNCTURE SITE LOCATION AND EVALUATE THE FEMORAL ARTERY CHARACTERISTICS PRIOR TO PLACING THE ANGIO-SEAL DEVICE BY INJECTING CONTRACT MEDIUM THROUGH THE PROCEDURE SHEATH AND USING FLUOROSCOPY. THE ANGIO-SEAL DEVICE INSTRUCTIONS FOR USE (IFU) CAUTIONS USE THAT IF THE PUNCTURE SITE IS AT OR DISTAL TO THE BIFURCATION OF THE SUPERFICIAL FEMORAL AND PROFUNDA FEMORIS ARTERY, AS THIS MAY RESULT IN THE ANGIO-SEAL DEVICE ANCHOR CATCHING ON THE BIFURCATION OR BEING POSITIONED INCORRECTLY, AND /OR COLLAGEN DEPOSITION IN THE VESSEL. THESE EVENTS MAY REDUCE BLOOD FLOW THROUGH THE VESSEL LEADING TO SYMPTOMS OF DISTAL ARTERIAL INSUFFICIENCY.