MAUDE Adverse Event Report: WILLIAM COOK EUROPE UNKNOWN; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number UNKNOWN

Device Problem Occlusion Within Device (1423)

Patient Problems Pain (1994); Thrombus (2101)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Catalog#: unknown but referred to a cook celect filter.Expiration date: unknown as lot# is unknown.Since catalog# is unknown the 510(k) could be either k0618815, k73374, k090140, k11219, k121057 or k121629.(b)(4).Investigation is still in progress.

Event Description

Description of event according to article: thirteen days postoperatively, the patient noticed acute-onset lumbar back pain with associated radicular pain.He endorsed painful episodes that emanated from a point of origin in his lumbar spine, symptoms progressed for several days until postoperative day 16, when he presented to the emergency department with incapacitating pain.The patient was unable to stand or ambulate independently.He had 2+ pitting edema of both ankles and calves.An ultrasound revealed occlusive thrombosis in the right greater saphenous vein, right common femoral, and right femoral vein.A nonocclusive thrombus was found in the right popliteal vein.The patient's inr upon arrival to the ed was subtherapeutic at 1.3.Computed tomographic (ct) imaging of the abdomen and pelvis was then ordered to confirm suspected thrombosis of the ivc filter.An occlusive thrombus was identified, beginning slightly proximal to the infrarenal ivc filter and extending caudally below the field of view in the right iliac and to the confluence of the internal and external iliac veins on the left.Venous thrombolysis was contraindicated for this patient because of his recent neurosurgical procedure.Therefore, urgent endovascular intervention was pursued with angiojet rheolytic thrombectomy (angiojet peripheral thrombectomy system, boston scientific, ma, usa), balloon push thrombectomy, and bilateral pelvic vein and infrarenal ivc angioplasty.Although extensive residual thrombosis remained following endovascular intervention, a slight degree of circulatory restoration was achieved and the patient reported mild improvement of his lower extremity pain and weakness.He was then admitted for observation and started on full dose anticoagulation therapy (1 mg/kg lovenox, twice daily).Over the course of the following two weeks, the patient was successfully transitioned to therapeutic anticoagulation on warfarin.Complete resolution of his lower extremity edema and continued improvement in his lower extremity pain was achieved within one week at therapeutic levels.He was discharged home in stable condition.At his three-month follow-up visit, the warfarin anticoagulation was within the therapeutic range, the lower extremity edema had resolved, and the resolution of his trigeminal neuralgia pain continued.Patient outcome: urgent endovascular intervention was pursued with angiojet rheolytic thrombectomy (angiojet peripheral thrombectomy system, boston scientific, ma, usa), balloon push thrombectomy, and bilateral pelvic vein and infrarenal ivc angioplasty.Acute-onset lumbar back pain with associated radicular pain; ivc occlusion.

Manufacturer Narrative

(b)(4).Catalog#: unknown but referred to a cook celect filter.Since catalog# is unknown the 510(k) could be either k0618815, k73374, k090140, k11219, k121057 or k121629.(b)(4).Summary of investigational findings: a celect-pt filter was placed due to a planned neurosurgical procedure with an insignificant anterior tilt in an ivc measuring only 12.4mm, which is not within ifu stating ivc must be 15-30mm.However, the ivc may be under distended from hypovolemia or dehydration or other causes, but this cannot be determined since no additional images were provided.Sixteen days after surgery the patient presented with lumbar back pain and radicular pain as well as bilateral lower extremity edema and ct images demonstrate subtle haziness surrounding the ivc and iliac veins with distention of the vein with occlusive thrombus, but after 1 week with anticoagulation the edema had resolved and the pain markedly improved.No evidence to suggest that this device was not manufactured according to specifications and nothing indicates that the filter did not perform as intended, e.G.Intended for the prevention of recurrent pulmonary embolism (pe) via placement in the vena cava.Cook medical will continue to monitor for similar events.

Event Description

Description of event according to journal article by loriaux et al.: thirteen days postoperatively, the patient noticed acute-onset lumbar back pain with associated radicular pain.He endorsed painful episodes that emanated from a point of origin in his lumbar spine, symptoms progressed for several days until postoperative day 16, when he presented to the emergency department with incapacitating pain.The patient was unable to stand or ambulate independently.He had 2+ pitting edema of both ankles and calves.An ultrasound revealed occlusive thrombosis in the right greater saphenous vein, right common femoral, and right femoral vein.A nonocclusive thrombus was found in the right popliteal vein.The patient¿s inr upon arrival to the ed was subtherapeutic at 1.3.Computed tomographic (ct) imaging of the abdomen and pelvis was then ordered to confirm suspected thrombosis of the ivc filter.An occlusive thrombus was identified, beginning slightly proximal to the infrarenal ivc filter and extending caudally below the field of view in the right iliac and to the confluence of the internal and external iliac veins on the left.Venous thrombolysis was contraindicated for this patient because of his recent neurosurgical procedure.Therefore, urgent endovascular intervention was pursued with angiojet rheolytic thrombectomy (angiojet peripheral thrombectomy system, boston scientific, (b)(4)), balloon push thrombectomy, and bilateral pelvic vein and infrarenal ivc angioplasty.Although extensive residual thrombosis remained following endovascular intervention, a slight degree of circulatory restoration was achieved and the patient reported mild improvement of his lower extremity pain and weakness.He was then admitted for observation and started on full dose anticoagulation therapy (1 mg/kg lovenox, twice daily).Over the course of the following two weeks, the patient was successfully transitioned to therapeutic anticoagulation on warfarin.Complete resolution of his lower extremity edema and continued improvement in his lower extremity pain was achieved within one week at therapeutic levels.He was discharged home in stable condition.At his three-month follow-up visit, the warfarin anticoagulation was within the therapeutic range, the lower extremity edema had resolved, and the resolution of his trigeminal neuralgia pain continued.Patient outcome: urgent endovascular intervention was pursued with angiojet rheolytic thrombectomy (angiojet peripheral thrombectomy system, boston scientific, (b)(4)), balloon push thrombectomy, and bilateral pelvic vein and infrarenal ivc angioplasty.Acute-onset lumbar back pain with associated radicular pain; ivc occlusion.

• Brand Name: UNKNOWN
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; 4632 bjaeverskov; DA
• Manufacturer Contact: marianne hoey ; sandet 6; bjaeverskov 4632 ; DA 4632 ; 56868686
• MDR Report Key: 6108736
• MDR Text Key: 60072127
• Report Number: 3002808486-2016-01436
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2016
• Initial Date FDA Received: 11/17/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/09/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 57 YR