ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENT
Report
- Report Number
- 3002808486-2016-00140
- Event Type
- Injury
- Date Received
- March 23, 2016
- Date of Event
- March 4, 2016
- Report Date
- March 4, 2016
- Manufacturer
- WILLIAM COOK EUROPE
- Product Code
- MIH
- UDI-DI
- 10827002335261
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
Narratives
(B)(4). SIMILAR DEVICE AS DEVICE WITH 510(K) P070016. INVESTIGATION IS STILL IN PROGRESS.
(B)(4). SIMILAR TO DEVICE UNDER 510(K) P070016. (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: THE RETURNED PRODUCT INVESTIGATION CONFIRMED THAT THE AMOUNT OF THE COATING WAS LIMITED ON THE DISTAL PART OF THE FLEXOR SHEATH IN COMPARISON TO THE PROXIMAL PART. THIS MAY CONFIRM THAT THE PRODUCT WAS NOT FULLY ADVANCED INSIDE THE PATIENT. IT IS UNFORTUNATELY NOT POSSIBLE TO DETERMINE IF THE COMPLAINT EVENT IS RELATED TO THE DEVICE OR THE PROCEDURE AS THE EVALUATION OF THE RETURNED DEVICE CONFIRMED THE EXISTENCE OF SOME OF THE HYDROPHILIC COATING. THE AMOUNT OF COATING ON THE SHEATH CAN GET AFFECTED IF THE ACCESS VESSELS ARE NOT COMPATIBLE WITH THE DIAMETER SIZE OF THE INTRODUCTION SYSTEM WHICH CAN RESULT IN DAMAGE TO THE INNER LAYER OF THE VESSEL WALL. THE CONSIDERATION OF PATIENT SELECTION INCLUDES ALSO STENOSIS, INTRAVASCULAR THROMBOSIS, OR CALCIFIED OR TORTUOUS VESSELS. THE IFU OF THE DEVICE STATES THE FOLLOWING TO BE CONSIDERED FOR PATIENT SELECTION: ADDITIONAL CONSIDERATIONS FOR PATIENT SELECTION INCLUDE BUT ARE NOT LIMITED TO: PATIENT¿S AGE AND LIFE EXPECTANCY. CO-MORBIDITIES (E.G., CARDIAC, PULMONARY OR RENAL INSUFFICIENCY PRIOR TO SURGERY, MORBID OBESITY). PATIENT¿S SUITABILITY FOR OPEN SURGICAL REPAIR. THE RISK OF ANEURYSM RUPTURE COMPARED TO THE RISK OF TREATMENT WITH THE ZENITH TX2 TAA ENDOVASCULAR GRAFT WITH PRO-FORM. ABILITY TO TOLERATE GENERAL, REGIONAL, OR LOCAL ANESTHESIA. ABILITY AND WILLINGNESS TO UNDERGO AND COMPLY WITH THE REQUIRED FOLLOW-UP: ILIO-FEMORAL ACCESS VESSEL SIZE AND MORPHOLOGY (THROMBUS, CALCIFICATION AND/OR TORTUOSITY) SHOULD BE COMPATIBLE WITH VASCULAR ACCESS TECHNIQUES AND ACCESSORIES OF THE DELIVERY PROFILE OF A 20 FRENCH TO 22 FRENCH VASCULAR INTRODUCER SHEATH, INCLUDING: ADEQUATE ILIAC/FEMORAL ACCESS COMPATIBLE WITH THE REQUIRED INTRODUCTION SYSTEMS, RADIUS OF CURVATURE GREATER THAN 35 MM ALONG THE ENTIRE LENGTH OF AORTA INTENDED TO BE TREATED. NON-ANEURYSMAL AORTIC SEGMENTS (FIXATION SITES) PROXIMAL AND DISTAL TO THE ANEURYSM: WITH A LENGTH OF AT LEAST 20 MM, WITH A DIAMETER MEASURED OUTER WALL TO OUTER WALL OF NO GREATER THAN 38 MM AND NO LESS THAN 20 MM, AND WITH AN ANGLE LESS THAN 45 DEGREES. THE FINAL TREATMENT DECISION IS AT THE DISCRETION OF THE PHYSICIAN AND PATIENT. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.
DESCRIPTION OF EVENT ACCORDING TO COMPLAINANT: THE STENT CANNOT GET THROUGH THE ARTERIA FEMORALIS DUE TO LACK OF HYDROPHILIC COATING. RESULT IN THE PATIENT ARTERIOSPASM AND ENDOCARDIUM DAMAGE. OPERATION ABORTED. PATIENT OUTCOME: THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
DESCRIPTION OF EVENT ACCORDING TO COMPLAINANT: THE STENT CANNOT GET THROUGH THE ARTERIA FEMORALIS DUE TO LACK OF HYDROPHILIC COATING. RESULT IN THE PATIENT ARTERIOSPASM AND ENDOCARDIUM DAMAGE. OPERATION ABORTED. PATIENT OUTCOME: THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 176162 | ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENT | MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | WILLIAM COOK EUROPE | 10827002335261 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Life Threatening |