POWERLINK SYSTEM

Report

Report Number: 2031527-2014-00145
Event Type: Injury
Date Received: May 20, 2014
Date of Event: April 27, 2014
Report Date: April 27, 2014
Manufacturer: ENDOLOGIX, INC.
Product Code: MIH
PMA / PMN Number: P040002
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TN, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

ENDOLOGIX CONTINUES TO INVESTIGATE THE REPORTED EVENT. ENDOLOGIX WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. DEVICE DISCARDED AT USER FACILITY.

Additional Manufacturer Narrative · 1

THE DEVICE REMAINS IMPLANTED IN THE PATIENT AND IS THEREFORE, NOT AVAILABLE FOR ANALYSIS. MEDICAL RECORDS AND COMPUTER TOMOGRAPHY IMAGING WERE PROVIDED AND REVIEWED BY A CLINICAL REPRESENTATIVE WITH THE FOLLOWING IMPRESSION: THE REVIEW INDICATES THE REPORTED ENDOLEAK IS CONFIRMED BASED ON CLINICAL ASSESSMENT OF OPERATIVE CT AND THE REPORT OF OCCLUDED DEVICE LIMBS IS INCONCLUSIVE, BECAUSE NO CONTRAST WAS GIVEN IN THE IMAGES PERFORMED AND REVIEWED. THERE WERE SEVERAL FACTORS THAT MIGHT HAVE BEEN INCONGRUENT WITH THE IFU AND SIZING RECOMMENDATIONS, AND MIGHT HAVE CONTRIBUTED TO THIS COMPLAINT: THE MAIN BODY AND CUFF WERE THE SAME DIAMETER; THE PRESENCE OF SEVERE CALCIFICATIONS AT THE AORTIC NECK AND THE BIFURCATION; THE PRESENCE OF THREE SETS OF PATENT LUMBAR ARTERIES. THE PATIENT HAD MANY RISK FACTORS FOR ANEURYSMAL DISEASE PROGRESSION, BUT THE HISTORY OF ANTICOAGULATION THERAPY MIGHT HAVE CONTRIBUTED TO THE PERSISTENT TYPE II ENDOLEAK, SEEN THROUGHOUT THE SEVEN YEAR COURSE AT THE PROXIMAL MARGIN AND AT THE BIFURCATION WHICH MIGHT HAVE CONTRIBUTED TO AORTIC REMODELING. YET, LATER (2012-2013) NEGATIVE AORTIC MODELING COULD ALSO HAVE CONTRIBUTED TO THIS COMPLAINT. THERE WAS A LONG NON SURVEILLANCE INTERVAL UNTIL THE ACUTE EVENT, WHICH COULD HAVE ALSO CONTRIBUTED TO THIS COMPLAINT. THERE MIGHT HAVE BEEN EVIDENCE OF AN INTERMITTENT TYPE III-A ENDOLEAK AT THE PROXIMAL STENT MARGIN, ALTHOUGH THIS MIGHT HAVE BEEN OBSCURED BY THE PERSISTENT TYPE II ENDOLEAK AT THAT REGION. A MANUFACTURING RECORD REVIEW WAS PERFORMED, THE LOT MET ALL RELEASE CRITERIA WITH NO ISSUES OR DEVIATIONS THAT WOULD EXPLAIN THE REPORTED EVENT. THE LOT USAGE HISTORY SHOWED ALL UNITS WERE CONSUMED AND NO OTHER UNITS WERE INVOLVED IN ANY SIMILAR EVENT. THE PRODUCT LABELING WAS REVIEWED AND CONFIRMED THAT THE REPORTED EVENT IS ADEQUATELY CAPTURED IN THE EXISTING LABELING. BASED ON THE REVIEW OF THE AVAILABLE INFORMATION, THE MOST LIKELY FACTORS THAT CONTRIBUTED TO THE ADVERSE PATIENT OUTCOME (STENT COMPONENT SEPARATION, THE TYPE III-A ENDOLEAK, AND THE RESULTING CONVERSION, VASCULAR REPAIR, COMPLICATION [ACUTE RENAL AND RESPIRATORY FAILURE; POST-OPERATIVE INFECTION]) APPEAR TO BE RELATED TO PERSISTENT TYPE II ENDOLEAKS, AN UNTREATED PARTIAL STENT COLLAPSE AND NON-SURVEILLANCE INTERVAL.

Description of Event or Problem · 1

IT WAS REPORTED THAT APPROXIMATELY 85 MONTHS POST-IMPLANT OF A BIFURCATED DEVICE, AN INFRARENAL AORTIC EXTENSION AND A LIMB EXTENSION, THE PATIENT PRESENTED EMERGENTLY AND SEPARATION BETWEEN THE BIFURCATED DEVICE AND THE PROXIMAL AORTIC EXTENSION WAS IDENTIFIED. REPORTEDLY, THE PATIENT PRESENTED WITH LOWER BACK PAIN, AND A COMPUTED TOMOGRAPHY (CT) SCAN IDENTIFIED COMPONENT SEPARATION. THE PATIENT HAD BEEN TREATED 20 MONTHS AFTER THE INITIAL IMPLANT DATE, WITH A PROXIMAL SUPRARENAL AORTIC EXTENSION, PLACED PROXIMAL TO THE INITIALLY IMPLANTED DEVICES, AND A COMPETITOR STENT, PLACED ABOVE THE RENAL ARTERIES. DUE TO THE FINDINGS IDENTIFIED DURING THE EMERGENT PRESENTATION, THE PHYSICIAN ELECTED TO ATTEMPT IMPLANTATION OF AN ADDITIONAL AORTIC EXTENSION, TO BRIDGE THE COMPONENTS; HOWEVER, IT WAS NOT POSSIBLE TO ADVANCE THE GUIDING CATHETER AND GUIDE WIRE UP TO THE LEVEL OF THE AORTA, ON EITHER THE RIGHT OR LEFT ACCESS SITES. THE PHYSICIAN ELECTED TO CONVERT TO OPEN REPAIR DUE TO THE ACCESSIBILITY DIFFICULTIES, AND DURING THE REPAIR IT WAS NOTICED THAT BOTH LIMBS OF THE BIFURCATED DEVICE WERE OCCLUDED. THE DEVICES WERE EXPLANTED AND THE PATIENT WAS TREATED WITH A SURGICAL GRAFT. THE PATIENT'S HOSPITAL COURSE INCLUDED A PEG TUBE FOR DYSPHAGIA, GROIN EXPLORATION FOR INFECTION SOURCE, INTUBATION FOR RESPIRATORY FAILURE. A CT SCAN DONE SEVEN DAYS POST OPERATIVELY DEMONSTRATED A POSSIBLE RETROPERITONEAL INFECTION AND SPLENIC INFARCTS. THE PATIENT CONTINUED TO DETERIORATE AND WAS PLACED ON COMFORT CARE. THE PATIENT EXPIRED ELEVEN DAYS POST OPERATIVELY.

Description of Event or Problem · 1

IT WAS REPORTED THAT APPROXIMATELY 85 MONTHS POST-IMPLANT OF A BIFURCATED DEVICE, AN INFRARENAL AORTIC EXTENSION AND A LIMB EXTENSION, THE PATIENT PRESENTED EMERGENTLY AND SEPARATION BETWEEN THE BIFURCATED DEVICE AND THE PROXIMAL AORTIC EXTENSION WAS IDENTIFIED. REPORTEDLY, THE PATIENT PRESENTED WITH LOWER BACK PAIN, AND A COMPUTED TOMOGRAPHY (CT) SCAN IDENTIFIED COMPONENT SEPARATION. THE PATIENT HAD BEEN TREATED 20 MONTHS AFTER THE INITIAL IMPLANT DATE, WITH A PROXIMAL SUPRARENAL AORTIC EXTENSION, PLACED PROXIMAL TO THE INITIALLY IMPLANTED DEVICES, AND A COMPETITOR STENT, PLACED ABOVE THE RENAL ARTERIES. DUE TO THE FINDINGS IDENTIFIED DURING THE EMERGENT PRESENTATION, THE PHYSICIAN ELECTED TO ATTEMPT IMPLANTATION OF AN ADDITIONAL AORTIC EXTENSION, TO BRIDGE THE COMPONENTS; HOWEVER, IT WAS NOT POSSIBLE TO ADVANCE THE GUIDING CATHETER AND GUIDE WIRE UP TO THE LEVEL OF THE AORTA, ON EITHER THE RIGHT OR LEFT ACCESS SITES. THE PHYSICIAN ELECTED TO CONVERT TO OPEN REPAIR DUE TO THE ACCESSIBILITY DIFFICULTIES, AND DURING THE REPAIR IT WAS NOTICED THAT BOTH LIMBS OF THE BIFURCATED DEVICE WERE OCCLUDED. THE DEVICES WERE EXPLANTED AND THE PATIENT WAS TREATED WITH A SURGICAL GRAFT. THE PATIENT REPORTEDLY TOLERATED THE PROCEDURE WELL.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
299924	POWERLINK SYSTEM	INFRARENAL PROXIMAL EXTENSION STENT	MIH	ENDOLOGIX, INC.	28-28-75L	W07-0067-013

Patients

Seq	Age	Sex	Outcome	Treatment
1	78 YR		Required Intervention