MAUDE MDR 433597

MDR report key
433597
Report number
MW1026999
Event key
0
Event type
3
Date of event
2002-10-15
Date received
2002-12-13
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
0
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1EECP DEVICE MANUFACTURED BY VASOMEDICAL, INC.EECPVASOMEDICAL, INC.DRNUNK**NY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12002-12-1301. H; 2. L; 3. R; 4. S

Event Narratives#

D

Patient 1

THE PATIENT EXPERIENCED SUBACUTE THROMBOSIS OF FEMORAL ARTERIAL TREE FOLLOWING TREATMENT WITH ENHANCED EXTERNAL COUNTERPULSATION. PT WAS RECEIVING TREATMENT WITH EECP FOR SEVERAL MONTHS AT THE TIME OF THE EVENT. PRIOR TO THE EVENT THEY HAD RECEIVED A TOTAL OF 47 EECP TREATMENTS FOR ANGINA PECTORIS AND MILD CONGESTIVE HEART FAILURE. FOLLOWING THE 47TH TREATMENT, PT EXPERIENCED THE ACUTE ONSET OF LOWER HIP PAIN THAT EXTENDED TO THE POPLITEAL FOSSA. THE PAINT WAS PERSISTENT AND PROGRESSIVE AND EVENTUALLY EXTENDED DOWN TO THE CALF. IT WAS LATER ACCOMPANIED BY FOOT NUMBNESS, AT WHICH OCCASION, PT PRESENTED TO THE ER. A VASCULAR EXAMINATION AT THAT TIME DETERMINED THAT THERE WAS NO EVIDENCE OF LIMB-THREATENING ISCHEMIA AND THE PATIENT WAS REFERRED FOR NEUROLOGICAL EXAMINATION AS AN OUTPATIENT. AN EMG TEST DISCLOSED EVIDENCE OF POLYNEUROPATHY THAT WAS FELT TO BE DUE TO A COMBINATION OF DIABETES AND POSSIBLE LIMB ISCHEMIA. APPROXIMATELY 6 WEEKS AFTER THE FINAL EECP TREATMENT AND ONSET OF SYMPTOMS, PT'S LEFT FOOT BECAME ACUTELY EDEMATOUS AND AGAIN PRESENTED TO THE ER. ON THIS OCCASION, PT WAS DIAGNOSED WITH LIMB-THREATENING ISCHEMIA OF THE LEFT LEG. MRA SHOWED THREE SEVERE STENOSES OF THE FEMORAL ARTERIAL TREE BELOW THE MID-THIGH ACCORDING TO THE PATIENT AND PT WAS EVENTUALLY TREATED WITH PTCA OF 2 OF THESE LESIONS THAT WERE ACCESSIBLE. CURRENTLY, 4 DAYS AFTER SURGERY, THE SYMPTOMS OF NUMBNESS AND SWELLING PERSIST.