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| Catalog Number HT066080 |
| Device Problem
Material Rupture (1546)
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| Patient Problems
Death (1802); Hemorrhage/Bleeding (1888)
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| Event Date 03/27/2017 |
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Event Type
Death
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Manufacturer Narrative
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The review of the manufacturing records verified that this lot met all pre-release specifications.(b)(4).Further investigation is being conducted and the information will be included in the final report.
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Event Description
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On (b)(6) 2017, the patient was treated with a gore® propaten® vascular graft to perform a bypass procedure.On (b)(6) 2017, day of discharge, it was reported to gore that the patient deceased for an unknown reason.An autopsy was performed which indicated a disruption of the implanted gore® propaten® vascular graft.It was stated that the gore® propaten® vascular graft rupture caused the patient to bleed to death.
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Manufacturer Narrative
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Event description was updated.Medical device returned to gore.
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Event Description
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The patient presented with a peripheral arterial disease, stage iii, an occluded femorofemoral crossover bypass, and a chronic occlusion of the left pelvic vessels.It was reported to gore that on (b)(6) 2017, the patient was treated with a gore® propaten® vascular graft to perform a cross over bypass procedure from the right common iliac artery to the left superficial femoral artery on the left.The operative report provided the following [translated]: ¿after the usual preparations (disinfection, sterile draping of the surgical field) and the administration of a single-shot antibiotic, a retroperitoneal incision was placed on the right side.After separating the lateral abdominal muscles, access to the femoral sheath was gained.The surgeon obtained exposure of the external iliac artery, sparing the centrally located ureter.The artery was heavily calcified.Therefore, the common iliac artery was dissected, and the internal iliac artery was exposed.The common iliac artery was suitable for bypass placement.All three arteries were looped, and clamping sites were created.At the same time, the left groin was dissected.Here, the superficial femoral artery and the profunda femoris artery were exposed and looped.As part of the prior surgery, the common femoral artery was centrally ligated, and an end-to-end bypass was created.After the anesthesiologists administered 5000 iu heparin, all three pelvic vessels were clamped.Longitudinal arteriotomy of the common iliac artery and enlargement of the incision using potts scissors were performed.Using a continuous suture technique and 5.0 tf suture material, end-to-side anastomosis of a 6 mm gore® propaten® vascular graft, which was cut in a beveled fashion, was established.Following completion of the suture and restoration of the blood flow, the physician clamped the gore® propaten® vascular graft with a lined fogarty clamp.The surgeon flushed the gore® propaten® vascular graft arms with heparinized saline solution.In the meantime, a thromboendarterectomy of the origins of the superficial femoral artery and both branches of the profunda femoris artery in the left groin area was performed.After that, the return flow was good.A smooth course of the gore® propaten® vascular graft was ensured.The bypass was then shorted, and an end-to-end anastomosis to the superficial femoral artery was created using continuous sutures and 5.0 tf1 material.Before completion of the anastomosis, flushing from all directions and rinsing with heparinized saline solution was performed.The surgeon completed the suturing and release of the blood flow.Then an end-to-end anastomosis was created between the two branches of the profunda femoris artery and a ptfe interposition graft (gore® propaten® vascular graft).After clamping again, an end-to-side anastomosis was created between the interposition graft and the crossover bypass using continuous suture technique and 5.0 tf1 suture material.Before completion of the suturing, flushing and rising with heparinized saline solution was carried out again.Release of the blood flow was established.A strong pulse was palpable over the profunda femoris artery and the superficial femoral artery on the left.The surgeon verified cessation of bleeding.Two redon drains were placed.In parallel, wound closure in layers and skin closure were completed.Sterile dressing was applied.¿ on (b)(6) 2017, day of discharge, it was reported to gore that the patient died because of an unknown reason.An autopsy was performed and it was reported to gore that the report stated ¿complete rupture of an iliaco-femoral crossover bypass, according to documentation, 7 days after surgery in (b)(6), with an initially inconspicuous postoperative course.¿ the report also stated ¿cause of death blood volume deficiency.¿ post-operative medical records and the autopsy report have not been provided.
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Manufacturer Narrative
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(b)(4).The devices were returned to w.L.Gore & associates for investigation.Submitted in formalin were two tissue and gore® propaten® vascular graft fragments.The first fragment consisted of tissue and a fragment of the bypass graft (vgf-1) making up the proximal anastomosis.Vgf-1 and native vessel were longitudinally transected prior to arrival at w.L.Gore & associates.Graft fragment was generally devoid of tissue on all surfaces with no tissue deposition at the surgical interface.Distal aspect of graft fragment had a tag of material attached at the site of the alignment markers.The native vessel exhibited multiple superficial linear tissue disruptions on the luminal surface of the proximal end.The second fragment consisted of the main body of the bypass graft (vgf-2) and distal anastomosis as well as the interposition graft segment (vgs).The proximal lumen of vgf-2 had a scant thin layer of friable dark black to brown/tan loosely adherent tissue present but remained widely patent.Proximal ablumen had focal friable red brown firmly adherent tissue present on one side.The proximal end of vgf-2 had a rough edge with a fragment of film attached and appears to align with the distal end of vgf-1.The main body had multifocal tan/yellow adipose tissue mixed with friable brown soft tissue present on the ablumen of the graft.Remaining areas are grossly devoid of tissue.All rings appeared intact except the distal most ring, nearest the anastomosis, which had a portion of the ring missing and blue suture present through the graft at this site.Vgf-2 site of anastomosis to femoral artery was a smooth interface with blue suture.Vgf-2 graft to graft anastomosis with vgs was a smooth transition with blue suture.Vgs was generally devoid of tissue on one aspect where multiple areas of evenly spaced serration marks were present on the abluminal surface.The other side of the segment ablumen had a foci of friable tan/brown firmly adherent soft tissue.Distal lumen was fully occluded with soft friable dark brown material and circular tan soft tissue present.Occlusion and tan tissue extended distal through majority submitted vessel.Vgs to vessel anastomosis was puckered with a slight edge overlap of graft to vessel, with blue suture.Histopathological examination of twenty-one tissue specimens from submitted tissue was performed.All examined tissue specimens exhibited significant alteration and effacement of normal vascular architecture secondary to the atherosclerotic disease process.Infectious agents were not observed.The devices were subjected to an enzymatic digestion process to remove biologic debris.Following digestion all devices were examined for material disruptions with the aid of a stereomicroscope and a scanning electron microscope (sem).Based on the observations from the gross evaluation, histology evaluation, and the post-digestion evaluation, there are signs that the device and native tissue were under tension.Radial film disruption was observed in the area where the device experienced a circumferential tear.It could not be confirmed whether the radial film had been disrupted during the initial implant procedure, or if it was an effect of the tear at the anastomosis.Sem images of the disrupted graft suggest an acute episode of tension leading to the tear, though the source of such tension could not be identified from clinical history.The clinical presentation of abrupt hemorrhage resulting rapidly in fatal hemodynamic shock is also consistent with an acute event.There is no evidence to suggest that the disruptions identified were associated with manufacturing processes or handling during investigation at w.L.Gore and associates.The remaining material disruptions identified, consisting of transections and surgical instrumentation marks, are consistent with a surgical procedure.W.L.Gore & associates cautions in the instructions for use of the gore® propaten® vascular graft within the iv.Technical information section that special care is required for axillofemoral, femorofemoral, and axillobifemoral bypass procedures.It states that the success of axillofemoral, femorofemoral, and axillobifemoral bypasses depends in large part on the implantation technique.Specific complications associated with improperly implanted gore® propaten® vascular grafts in these positions may include suture hole elongation and mechanical disruption or tearing of the graft, suture line, or host vessel.Failure to follow these techniques may result in extreme blood loss, loss of limb function, loss of limb, or death.Although experience indicates that the incidence of these complications is extremely low, the described techniques within the instructions for use must be employed if the treatment plan includes one of the above procedures.¿ consider the patient¿s body weight and posture when determining the lengths of the tissue tunnel and the graft.¿ drape the patient to allow full movement of the arm, shoulder girdle or legs when determining correct graft length.¿ allow sufficient length to avoid stressing the axillary or femoral anastomoses throughout the full range of movement of the arm, shoulder girdle, or legs.Surgeons suggest that the graft be placed under both the pectoralis major and pectoralis minor.¿ cutting the graft slightly longer than necessary has been reported by some surgeons to reduce further the risk of stressing the graft or the anastomoses.The patient should be cautioned against extreme or abrupt movements of the arm, shoulder, or legs during a convalescent period of six to eight weeks to allow for adequate healing.Routine activities such as reaching out in front, raising arms above the shoulder level, throwing, pulling, striding, or twisting should be avoided.Failure to follow there procedures may result in extreme blood loss, loss of limb function, loss of limb, or death.Within the v.Possible complications with the use of any vascular prosthesis complications which may occur in conjunction with the use of any vascular prosthesis include but are not limited to: mechanical disruption or tearing of the suture line, graft, and/or host vessel; and excessive suture hole bleeding.The section vi.Operative techniques states that when applying clamps, care should be taken to avoid mechanical damage to, or disruption of, the graft.Use the appropriate atraumatic or guarded (for example, rubber shod) clamps.Avoid repeated, localized clamping or excessive clamping on any section of the graft.Further it states that failure to correctly cut the gore® propaten® vascular graft may damage the outer reinforcing layer and may result in aneurysmal dilatation or reduced suture retention strength.Anastomotic angles vary with the vascular procedure being performed.Use of an appropriate anastomotic angle may minimize undue stresses which may lead to mechanical disruptions of the graft, host vessel, and/or suture lines.Use only nonabsorbable, monofilament sutures, such as gore-tex® suture, of a size appropriate for the nature of the reconstruction.Do not use a full radius cutting needle as it may damage the graft.Undue anastomotic bleeding may occur if excessive tension causes suture holes to elongate or tear, if the needle-to-suture diameter ratio is too great, or if gaps occur between the graft and the host vessel.Use appropriate suture placement and bites and avoid undue tension on the suture line.Hemostatic agents such as topical thrombin and surgicel® absorbable hemostat may be used to minimize anastomotic bleeding.The manufacturers¿ instructions for these products should be observed.Within the section operative techniques ¿ tensioning the following is mentioned: when handling or tensioning the gore® propaten® vascular graft, avoid using excessive force or high rates of force which could lead to graft disruption.
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Event Description
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Additional details regarding the patient¿s clinical course were ascertained from a review of medical records and are as follows: a translated operative reported dated (b)(6) 2017 indicates the patient underwent implantation of a crossover bypass graft whereby a gore® propaten® vascular graft was implanted from the right common iliac artery to the left superficial femoral artery and profunda femoris bypass on the left.The records indicate a diagnosis of ¿stage iii peripheral arterial disease on the left with occluded femorofemoral crossover bypass graft and chronic occlusion of the left pelvic vessels.¿ the (b)(6) 2017 translated operative report dated states: ¿the surgeon obtained exposure of the external iliac artery, sparing the centrally located ureter.The artery was heavily calcified.Therefore, the common iliac artery was dissected, and the internal iliac artery was exposed.The common iliac artery was suitable for bypass placement.All three arteries were looped, and clamping sites were created.At the same time, the left groin was dissected.Here, the superficial femoral artery and the profunda femoris artery were exposed and looped.As part of the prior surgery, the common femoral artery was centrally ligated, and an end-to-end bypass was created.¿ the (b)(6) 2017 translated operative report continues: ¿after the anesthesiologists administered 5000 iu heparin, all three pelvic vessels were clamped.Longitudinal arteriotomy of the common iliac artery and enlargement of the incision using potts scissors were performed.Using a continuous suture technique and 5.0 tf suture material, end-to-side anastomosis of a 6 mm gore® propaten® vascular graft, which was cut in a beveled fashion, was established.Following completion of the suture and restoration of the blood flow, the physician clamped the gore® propaten® vascular graft with a lined fogarty clamp.The surgeon flushed the gore® propaten® vascular graft arms with heparinized saline solution.In the meantime, a thromboendarterectomy of the origins of the superficial femoral artery and both branches of the profunda femoris artery in the left groin area was performed.After that, the return flow was good.A smooth course of the gore® propaten® vascular graft was ensured.The bypass was then shorted, and an end-to-end anastomosis to the superficial femoral artery was created using continuous sutures and 5.0 tf1 material.Before completion of the anastomosis, flushing from all directions and rinsing with heparinized saline solution was performed.¿ the (b)(6) 2017 translated operative report further states: ¿the surgeon completed the suturing and release of the blood flow.Then an end-to-end anastomosis was created between the two branches of the profunda femoris artery and a ptfe interposition graft (gore® propaten® vascular graft).After clamping again, an end-to-side anastomosis was created between the interposition graft and the crossover bypass using continuous suture technique and 5.0 tf1 suture material.Before completion of the suturing, flushing and rising with heparinized saline solution was carried out again.Release of the blood flow was established.A strong pulse was palpable over the profunda femoris artery and the superficial femoral artery on the left.The surgeon verified cessation of bleeding.Two redon drains were placed.In parallel, wound closure in layers and skin closure were completed.Sterile dressing was applied.¿ further information was reported to gore by the physician.The physician reported that there were no clamps placed in the area of the graft tear.He gave his opinion that, given the orientation of the graft, the most tension was likely to be at the heal of the r.Iliac (proximal) anastomosis.The physician reported that one possible cause of excess tension on the graft was the weight of the bowel on the graft, though the patient was not obese.The physician also reported that both the proximal and distal arteries were diseased, and that the procedure was being attempted as a last chance to save the patient's leg.The physician was not aware of any notable events (e.G., a fall) during the postoperative period prior to the graft tear.Medical records detailing the patient¿s post-operative course from (b)(6) 2017 were not provided.On (b)(6) 2017 the following was reported: ¿on (b)(6) 2017 the day of discharge, the patient died, and a forensic doctor from the hospital stated the gore endoprosthesis separated circularly, causing the patient to exsanguinate.¿ a translated autopsy reported dated (b)(6) 2017 indicates the following findings identified during internal examination of the thorax and abdomen: ¿on the main incision, the adipose tissue at the height of the navel measures up to 2 cm.The soft tissues of the abdomen and thorax exhibit distinct fluid accumulation.In the proximity of the pubic bone, an implant of vascular graft type is found, which will be described in more detail later.¿ ¿the abdominal cavity contains blood, some of which is liquid and some is loosely coagulated.It has a volume of 1450 ml.¿ ¿at the initial inspection without further mobilization, no source of bleeding can be identified.¿ the (b)(6) 2017 translated autopsy report internal exam findings of the thorax and abdomen continue: ¿adhesions between intestinal loops are found in the right lower abdomen.After careful detachment, an opening is found in the tissue from which a small amount of liquid blood drains upon compression of the surrounding soft tissue.This section of the vessel is then exposed, with the incision line running parallel to the vessel.The examination reveals a completely severed vascular graft located there.The affected region is then exposed from the direction of the aorta.About 6.5 cm to 7 cm caudally of the bifurcation of the aorta into the two common iliac arteries, suture material with a vessel graft below is found.The vessel suture is sufficient and leak-tight.There are no signs of local changes here.Approximately 2 mm caudally of the deepest point of the vessel suture, the vascular graft is completely severed.The severance margin is slightly irregular.¿ the (b)(6) 2017 translated autopsy report internal exam findings of the thorax and abdomen further state: ¿the surrounding soft tissue exhibits black glossy hemorrhage.¿ ¿further soft tissue dissection is performed in the area of the graft rupture.Between the two ruptured ends, a gap of approximately 2 mm to 3 mm is found.¿ ¿at a clearance of 2 cm to almost 3 cm cranially of the vessel suture, the tunica intima of the common iliac artery is torn transversally on the right side.The vessel wall exhibits slightly black glossy hemorrhage in this location.¿ ¿upon examination of the aorta, approx.3 cm cranially of the bifurcation of the common iliac artery, an aneurysmal bulge of about 5.5 cm is found.The vessel wall is intact here.¿ the (b)(6) 2017 translated autopsy report internal exam findings of the thorax and abdomen continue: ¿further dissection of the graft is performed.It can be traced transversely in the abdominal soft tissue to the region of the left femoral artery.Surgical reconstruction of the vascular bifurcation has been performed.Sufficient sutures are found without signs of local complications.There are no signs of other local complications in the surgical area.¿ the (b)(6) 2017 translated autopsy report ¿order and prior history¿ further states: ¿on (b)(6) 2017, a surgical procedure was reportedly performed, specifically an iliacofemoral crossover bypass right -> left (authors¿ note: placement of a vascular graft between the right common iliac artery and the left femoral artery) with reconstruction of the femoral artery bifurcation on the left (authors¿ note: bifurcation of the left femoral artery).According to the medical report, the procedure was performed without complications.¿ the (b)(6) 2017 translated autopsy report ¿order and prior history¿ continues: ¿according to the report, the patient was postoperatively monitored on the intermediate care ward.The heart and lung function were stable.Ms.(b)(6) was transferred to the ward on the following day.The further postoperative care was without complications as well.The drains were removed on time.The wounds showed a primary (authors¿ note: normal) healing tendency.The implanted bypass was sonographically patent.The patient was mobilized without complications.Due to reperfusion edema (authors¿ note: increased fluid accumulation, apparently in the soft tissue of the legs), moderate compression therapy with compression stockings was administered.¿ the (b)(6) 2017 translated autopsy report ¿order and prior history¿ further states: ¿on (b)(6) 2017, the planned discharge date, ms.(b)(6) collapsed on the floor of the ward, requiring resuscitation.The resuscitation attempts failed; ms.(b)(6) was pronounced dead.¿ the (b)(6) 2017 autopsy report ¿assessment of findings¿ states: ¿the main finding of the forensic examination¿was extensive hemorrhage into the abdominal cavity.The extent of hemorrhage and the signs of pronounced anemia of the internal organs that were found during the autopsy explain the clinically documented sudden collapse of ms.(b)(6) as well as her death as a result of volume depletion shock.No signs of a competing cause of death were identified during the autopsy.¿ the (b)(6) 2017 translated autopsy report ¿assessment of findings¿ continues: ¿the source of bleeding was the complete rupture of an arterial vascular bypass graft between the right common iliac artery and the left femoral artery, which was implanted 7 days before death according to clinical documents.The rupture site was a few millimeters to nearly 1 cm caudally of the implantation site in the right common iliac artery.The autopsy did not show any evidence of mechanical problems arising as a result of the surgical procedure.All sutures were normal and free of complications.From a forensic point of view, the autopsy results show no signs of medical wrongdoing.¿ the (b)(6) 2017 translated autopsy report indicates the following: ¿cause of death: blood volume depletion shock.¿ ¿manner of death: unclear.¿ the gore® propaten® vascular graft was explanted during the (b)(6) 2017 autopsy and was returned to gore for evaluation.
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