FDA.reportPublic FDA data

MAUDE MDR 9772477

MDR report key
9772477
Report number
2017233-2020-00134
Event key
0
Event type
3
Date of event
2020-01-06
Date received
2020-02-29
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
SIBYLLE STAERK
Address
1500 N. 4TH STREET AZ
Phone
928-928-9285
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1GORE PROPATEN VASCULAR GRAFTPROSTHESIS, VASCULAR GRAFTW.L. GORE & ASSOCIATESDSYH060040AR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-02-2901. H

Event Narratives#

N

Patient 1

(B)(4).

D

Patient 1

THIS CLINICAL TRIAL CASE CONCERNS A (B)(6) YEAR OLD WHITE MALE SUBJECT (B)(6). A STUDY CONDUIT WAS PLACED IN HIS LEFT UPPER ARM ON (B)(6) 2017. ON (B)(6) 2020, 1085 DAYS AFTER THE STUDY CONDUIT WAS SURGICALLY INSERTED, THE PATIENT EXPERIENCED SEVERE INFECTION OF THE VASCULAR ACCESS AND WAS SUBSEQUENTLY HOSPITALIZED. REPORTEDLY, THE PATIENT PRESENTED WITH ERYTHEMA, SWELLING AND LOCAL PAIN OVER THE STUDY CONDUIT. TEMPERATURE WAS 36.9? CELSIUS. AN ULTRASOUND EXAMINATION SHOWED "FULLNESS" AROUND THE STUDY CONDUIT, IN THE REGION OF THE SKIN ERYTHEMA. THE STUDY CONDUIT APPEARED COMPRESSED BY THE "FULLNESS" IN THIS SEGMENT. IT WAS STATED, THAT PARTICLES MOVED INSIDE THE "FULLNESS" WITHOUT FLOW ON DOPPLER. IT WAS REPORTED, THAT THE PATIENT WAS INITIATED WITH AMOXICILLIN/CLAVULANATE AND CIPROFLOXACIN. A TEMPORARY JUGULAR CATHETER WAS PLACED FOR DIALYSIS. ON (B)(6) 2020, BLOOD CULTURES YIELDED STAPHYLOCOCCUS LUGDUNENSIS. ON (B)(6) 2020, ASPIRATION CULTURES FROM THE SITE OF INFECTION SUBSEQUENTLY YIELDED STAPHYLOCOCCUS LUGDUNENSIS. ON (B)(6) 2020, THE PATIENT REPORTED IMPROVEMENT OF THE SWELLING AND PAIN. AMOXICILLIN/CLAVULANATE AND CIPROFLOXACIN WERE DISCONTINUED AND INTRAVENOUS CEFAZOLIN WAS STARTED. ON (B)(6) 2020, THE PATIENT UNDERWENT DIALYSIS VIA TEMPORARY JUGULAR CATHETER. ON (B)(6) 2020, 1094 DAYS AFTER THE STUDY CONDUIT WAS SURGICALLY INSERTED, THE PATIENT EXPERIENCED SEVERE VASCULAR ACCESS SITE BLEEDING WHICH REQUIRED URGENT SURGERY AND PROLONGED HOSPITALIZATION. A WOUND IN THE SKIN WITH NECROTIC MARGINS AND UNHEALTHY SUBCUTANEOUS TISSUE THAT SEEMED INFILTRATED WAS NOTED. AN INCISION WAS MADE IN THE ARM OVER THE STUDY CONDUIT IN THE REGION OF THE WOUND. THE STUDY CONDUIT WAS DISCONNECTED FROM THE SURROUNDING TISSUE AND PERFORATED. THERE WAS SEPARATION TOWARD THE ANASTOMOSIS UNTIL REACHING A HEALTHY REGION IN WHICH THE STUDY CONDUIT WAS SEEN WELL-ADHERING TO THE TISSUE. THERE WAS NO NEED TO PERFORM SEPARATION AROUND THE ANASTOMOSIS. CLOSURE OF THE STUDY CONDUIT IN THIS REGION WAS PERFORMED, LEAVING A SMALL PART OF THE STUDY CONDUIT IN THE REGION OF THE ARTERIAL ANASTOMOSIS THAT APPEARED HEALTHY AND WELL CONNECTED TO THE TISSUES. FOLLOWING THIS, GOOD BRACHIAL AND RADIAL PULSES WERE ASCERTAINED. NEXT, COMPLETION OF THE SEPARATION TOWARD THE UPPER ARM WAS PERFORMED, AND ANOTHER INCISION WAS MADE IN THE MIDDLE OF THE ARM ABOVE THE STUDY CONDUIT, IN THE SKIN AND SUBCUTANEOUS TISSUE. SEPARATION OF THE STUDY CONDUIT WAS DONE UNTIL REACHING A REGION THAT WAS WELL-ADHERENT AND WITH HEALTHY SURROUNDING TISSUE. INCISION AND DISCONNECTION AND REMOVAL OF THIS SEGMENT OF THE STUDY CONDUIT WAS PERFORMED AND SENT FOR PATHOLOGY. IN THE REGION OF THE SKIN AND SUBCUTANEOUS TISSUE THAT APPEARED INFECTED, DEBRIDEMENT WAS PERFORMED AND THE TISSUE WAS SENT FOR PATHOLOGY, AND SUBSEQUENTLY YIELDED STAPHYLOCOCCUS LUGDUNENSIS. ANAEROBIC CULTURE RESULTS WERE PENDING AT THE TIME. THE SITE WAS RINSED WITH POVIDONE/IODINE AND HEMOSTASIS WAS OBTAINED WITH NO ACTIVE BLEEDING. FOLLOWING THE PROCEDURE, BOTH OF THE EVENTS WERE CONSIDERED RESOLVED. ON (B)(6) 2020, THE PATIENT UNDERWENT PLACEMENT OF A PERMACATH AND THE TEMPORARY DIALYSIS CATHETER WAS REMOVED. ON (B)(6) 2020, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL IN STABLE CONDITION. HE HAD NO FEVER THROUGHOUT HOSPITALIZATION. THE SURGICAL WOUND IN THE ARM WAS WITHOUT DISCHARGE OR SIGNS OF INFECTION AND A PULSE WAS PALPATED IN THE HAND. THE INFECTIOUS DISEASE PHYSICIAN RECOMMENDED CONTINUATION OF CEFAZOLIN TREATMENT 2 G AFTER DIALYSIS FOR 8 WEEKS DUE TO S. LUGDUNENSIS, AND FOLLOW UP WITH THE INFECTIOUS DISEASE PHYSICIAN.