GORE® DRYSEAL FLEX INTRODUCER SHEATH
Report
- Report Number
- 3007284313-2021-01655
- Event Type
- Death
- Date Received
- November 11, 2021
- Date of Event
- October 20, 2021
- Report Date
- June 3, 2022
- Manufacturer
- W. L. GORE & ASSOCIATES, INC.
- Product Code
- DYB
- PMA / PMN Number
- K160254
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
IMAGES WERE PROVIDED TO GORE FOR EVALUATION AND SHOWED THE FOLLOWING: IMAGES PROVIDED FOR EVALUATION ARE PRE-IMPLANT CTA. DIAMETER JUST DISTAL TO THE LEFT RENAL MEASURES ~ 19 MM. DIAMETER ~ 5 MM DISTAL TO THE LEFT RENAL MEASURES ~ 17 MM. DIAMETER ~ 10 MM DISTAL TO THE LEFT RENAL MEASURES ~ 16 MM. DIAMETER ~ 15 MM DISTAL TO THE LEFT RENAL MEASURES ~ 30 MM. THERE APPEARS TO BE A REVERSE TAPER PRESENT AT THE PROXIMAL NECK. THERE DOES NOT APPEAR TO BE 15 MM OF AORTIC NECK AVAILABLE. DIAMETERS IN THE 3.3 CM PROXIMAL TO THE AORTIC BIFURCATION RANGE FROM 9.6 MM ¿ 16.6 MM. DISTAL WAIST DIAMETERS MEASURE < 18 MM. DIAMETERS IN THE RCI RANGE FROM 5.4 MM ¿ 7.2 MM (JUST PROXIMAL TO THE RIIA). DIAMETERS IN THE REI RANGE FROM 5.1 MM ¿ 6.4 MM. DIAMETERS IN THE LCI RANGE FROM 7.1 MM ¿ 8.3 MM. DIAMETERS IN THE LEI RANGE FROM 5.3 MM ¿ 6.4 MM. G3: CORRECTED INFORMATION.
H6: CODE 3221: THE LOT NUMBER WAS UNAVAILABLE WHEREFORE NO REVIEW OF THE MANUFACTURING RECORDS COULD BE CONDUCTED.
PATIENT MEDICAL HISTORY INCLUDES BUT IS NOT LIMITED TO: CAD. CONCOMITANT MEDICAL PRODUCTS: PATIENT MEDICATIONS INCLUDE BUT ARE NOT LIMITED TO: UNSPECIFIED MEDICATIONS FOR TREATMENT OF HYPERTENSION AND CAD.
ON (B)(6) 2021, IT WAS REPORTED THAT THE PATIENT EXPIRED. THE PHYSICIAN STATED THE CAUSE OF DEATH WAS MULTISYSTEM ORGAN FAILURE. THE PHYSICIAN STATED THE MULTISYSTEM ORGAN FAILURE COULD HAVE BEEN CAUSED BY THE EMERGENT CONVERSION DUE TO THE RUPTURE OF THE AORTA WHEN BALLOONING THE TWO LIMBS DOWN CLOSE TO THE AORTIC BIFURCATION. SHE ENDED UP HAVING ISSUES DUE TO PROLONGED ANESTHESIA OF ALMOST 8 1/2 TO 9 HOURS. AS WELL THE PATIENT WAS NOT AN IDEAL SURGICAL CANDIDATE IN THE FIRST PLACE AND THAT WAS THE REASON FOR ATTEMPTING THE ENDOVASCULAR REPAIR.
THE FOLLOWING DETAILS WERE REPORTED TO GORE: PATIENT WAS EVALUATED FOR EVAR AND PHYSICIAN NOTED THAT PATIENT WAS NOT A GOOD SURGICAL CANDIDATE. CONCERNS THAT WERE NOTED ON THE FILM REVIEW, 1) SHORT PROXIMAL AORTIC NECK- 1-1.2 CM, 2) DISTAL AORTA WAS SMALL, 15-17 MM, OVER A 3 CM LENGTH, 3) ACCESS WAS CALCIFIED AND 5.5-6 MM BILATERALLY. AFTER ALL CONCERNS DISCUSSED THE DOCTOR WANTED TO PROCEED WITH EVAR. AFTER GAINING ACCESS VIA BILATERAL FEMORAL CUTDOWNS SHEATHS WERE ADVANCED INTO THE MID AND PROXIMAL INFRARENAL AORTA. THE DEVICE, CXT261212, WAS ADVANCED THRU THE 16 FRENCH SHEATH AND PLACED AT THE LEVEL OF THE RENAL ARTERIES. AN ANGIOGRAM WAS PERFORMED AND THE DEVICE WAS DEPLOYED WITH OUT INCIDENT. THE GATE WAS NOTED TO BE COMPRESSED, BUT CANNULATION WAS PERFORMED WITHOUT DIFFICULTY. A PIGTAIL WAS ADVANCED AND SPUN TO CONFIRM THAT THE WIRE WAS IN THE BODY OF THE GRAFT. AN INJECTION WAS PERFORMED FROM THE CONTRA SIDE, THRU THE 12 FRENCH SHEATH. A LIMB WAS THEN ADVANCED AFTER THE SHEATH AND DILATOR WERE PLACED INTO THE GATE OF THE TRUNK. SHEATH WAS DRAWN BACK BELOW THE LEVEL OF THE LEFT HYPOGASTRIC ARTERY AND DEPLOYED. THE TRUNK WAS THEN FULLY DEPLOYED AND AN EXTENSION LIMB, WHICH WAS MARKED AFTER DOING AN INJECTION OF CONTRAST THRU THE SHEATH WAS PLACE TO THE LEVEL OF THE RIGHT HYPOGASTRIC ARTERY. THE PROXIMAL PART OF THE TRUNK WAS BALLOONED WITH A CODA BALLOON AND KISSING 12 MM BALLOON WERE USED IN THE LIMBS. THEN BILATERAL 10MM DIAMETER LUMINEX SELF EXPANDING STENTS WERE PLACE IN THE EXTERNAL ILIAC ARTERIES. THE PATIENTS BLOOD PRESSURE WAS NOTED BY ANESTHESIA TO BE DROPPING. ANGIOS WERE PERFORMED AND NO VISUAL LEAK COULD BE SEEN, THE LEFT ILIAC DISTAL TO THE GRAFT WAS DISSECTED AND THE DOCTOR FELT THAT COULD BE THE ISSUE. A 13X10 VIABAHN WAS PLACED IN THE LIMB AND ACROSS THE LEFT HYPOGASTRIC ARTERY. AFTER PLACING THE VIABAHN AND THE PATIENT RECEIVING BLOOD PRODUCTS THE BLOOD PRESSURE IMPROVED. ABOUT 5 MINS AFTER THAT THE BLOOD PRESSURE DROPPED AGAIN AND THE DOCTOR DECIDED TO OPEN THE PATIENTS BELLY. THE CODA BALLOON WAS ADVANCED INTO AIRY AT THE LEVEL OF THE VISCERAL VESSELS AND INFLATED, WHICH STABILIZED THE BLOOD PRESSURE. ONCE EXPOSURE WAS DONE, THE AORTA WAS TORN AT THE DISTAL AORTA, WHERE THE LIMBS WERE IN THE 15-17 MM DISTAL AORTA DIAMETER. THE PATIENT WAS CONVERTED TO AN AORTA BIFEMORAL GRAFT AND WAS STABILE AND TRANSFERRED TO THE UNIT AFTER SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1699402 | GORE® DRYSEAL FLEX INTRODUCER SHEATH | INTRODUCER, CATHETER | DYB | W. L. GORE & ASSOCIATES, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Female | Death| O| R| H| S| L |