UNKNOWN
Report
- Report Number
- 1820334-2024-00895
- Event Type
- Injury
- Date Received
- July 2, 2024
- Date of Event
- June 13, 2024
- Report Date
- September 30, 2024
- Manufacturer
- COOK INC
- Product Code
- DQX
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
G4: PMA/510(K) NUMBER = K171764. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
SUMMARY OF EVENT: AS REPORTED VIA A POST-MARKET CLINICAL FOLLOW-UP (PMCF) STUDY, AN UNKNOWN BENTSON WIRE WAS USED DURING A PROCEDURE INVOLVING TREATMENT OF A JUXTA-RENAL (NECK LESS THAN TEN MILLIMETERS) DEGENERATIVE ABDOMINAL AORTIC ANEURYSM, WHICH HAD NOT GROWN MORE THAN ONE CENTIMETER PER YEAR. THE PROCEDURE WAS PERFORMED (B)(6) 2024, USING GENERAL ANESTHESIA AND NEAR-INFRARED SPECTROSCOPY NEUROMONITORING. PERCUTANEOUS ACCESS WAS OBTAINED IN THE LEFT FEMORAL ARTERY AND CUT-DOWN ACCESS WAS OBTAINED IN THE RIGHT FEMORAL AND RIGHT AXILLARY ARTERIES. AN ILIAC ENDOVASCULAR CONDUIT WAS PERFORMED. AFTER ARTERIES WERE REVASCULARIZED WITH PLACEMENT OF A CUSTOM-MADE, FENESTRATED STENT GRAFT, SIDE-BRANCHES WERE CATHETERIZED AND OTHER MANUFACTURERS¿ BRIDGING STENTS WERE PLACED. ANOTHER MANUFACTURER¿S 7X27-MILLIMETER STENT WAS SUCCESSFULLY PLACED IN THE SUPERIOR MESENTERIC ARTERY. ANOTHER MANUFACTURER¿S 5X28-MILLIMETER STENT WAS PLACED IN THE RIGHT RENAL ARTERY, AND A 6X22-MILLIMETER STENT WAS PLACED IN THE LEFT RENAL ARTERY. ALL BRIDGING STENTS-MAINTAINED PATENCY WITH NORMAL END-ARTERY PERFUSION. THERE WERE NO TECHNICAL DIFFICULTIES IN THE SUCCESSFUL DELIVERY AND DEPLOYMENT OF THE CUSTOM-MADE DEVICE. A COOK DISTAL BODY ENDOVASCULAR GRAFT WAS ALSO SUCCESSFULLY PLACED DURING THE PROCEDURE. ESTIMATED BLOOD LOSS DURING THE PROCEDURE WAS 900-MILLILITERS. THE PATIENT DID NOT HAVE ANY SIGNIFICANT MEDICAL PROBLEMS OR COMPLICATIONS DURING THE ORIGINAL PROCEDURE. A POST-PROCEDURAL ANGIOGRAM, PERFORMED THE SAME DAY AS THE ORIGINAL PROCEDURE, SHOWED PATENCY OF ALL TARGET VESSELS AND STENTS. NO ENDOLEAK WAS NOTED. ALL SIDE-BRANCH STENTS WERE INTACT, AND THERE WERE NO ISSUES WITH STENT GRAFT INTEGRITY. NINE DAYS AFTER THE ORIGINAL PROCEDURE, DISSECTION OF THE SUPERIOR MESENTERIC AND RIGHT RENAL ARTERIES WAS NOTED. THE RIGHT RENAL ARTERY (RRA) DISSECTION DID NOT LIMIT FLOW AND NO INTERVENTION WAS REQUIRED. THE SUPERIOR MESENTERIC ARTERY (SMA) DISSECTION WAS SUCCESSFULLY TREATED PERCUTANEOUSLY WITH PLACEMENT OF AN ENDOVASCULAR COVERED STENT WITHIN THE SMA, NINE DAYS AFTER THE ORIGINAL PROCEDURE. PER THE REPORTER, IT IS POSSIBLE THAT AN UNKNOWN COOK BENTSON WIRE, USED DURING CATHETERIZATION OF THE ARTERIES, CONTRIBUTED TO THE DISSECTIONS; HOWEVER, THERE HAS BEEN NO ALLEGED MALFUNCTION OF THE WIRE. PER THE REPORTER, THE EVENT DID NOT OCCUR DUE TO A DEVICE DEFICIENCY. THE REPORTER ALSO STATED THAT IT IS POSSIBLE THAT THE TREATED DISEASE CONTRIBUTED TO THE EVENT, NOTING THAT ¿POST ANEURYSM DISSECTIONS ARE FREQUENTLY SEEN.¿ THE PATIENT RECOVERED WITHOUT FURTHER ISSUE. INVESTIGATION EVALUATION: REVIEWS OF THE INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL PROCEDURES WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED TO COOK FOR INVESTIGATION. THE LOT NUMBER WAS NOT PROVIDED TO COOK, AND A GLOBAL SHIPMENT SEARCH WAS UNABLE TO DEFINITIVELY DETERMINE THE LOT; THEREFORE, THE DEVICE HISTORY RECORD AND COMPLAINT HISTORY COULD NOT BE REVIEWED. THE PRODUCT IFU WARNS AGAINST FORCEFUL ANGULATION OF THE DEVICE AND CAUTIONS NOT TO TORQUE THE WIRE GUIDE. THE IFU ALSO CAUTIONS THE USER ¿DO NOT ADVANCE OR MANIPULATE THE WIRE GUIDE WITHOUT VISUAL EVIDENCE OF THE CORRESPONDING MOVEMENT OF THE DISTAL TIP¿ AND ¿DO NOT ADVANCE OR WITHDRAW A WIRE GUIDE WHEN RESISTANCE IS ENCOUNTERED, AS A PERFORATION COULD OCCUR.¿ A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE. THE INFORMATION PROVIDED UPON REVIEW OF THE DMR AND IFU SUGGESTS THAT THERE IS EVIDENCE THE DEVICE WAS MANUFACTURED TO SPECIFICATION. THERE IS NO EVIDENCE OF NON-CONFORMING DEVICES IN-HOUSE OR IN THE FIELD. BASED ON THE INFORMATION PROVIDED AND THE RESULTS OF THE INVESTIGATION, COOK HAS CONCLUDED THAT PROCEDURAL COMPLICATIONS AND THE PATIENT¿S DISEASE LIKELY CONTRIBUTED TO THIS EVENT. THERE HAS BEEN NO ALLEGED MALFUNCTION OF THE WIRE GUIDE IN THIS CASE, AND THE DISSECTIONS WERE FOUND NINE DAYS AFTER THE PROCEDURE IN WHICH THE BENTSON WIRE WAS USED. A POST-PROCEDURAL ANGIOGRAM PERFORMED THE SAME DAY AS THE ORIGINAL PROCEDURES SHOWED PATENCY OF ALL VESSELS. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED AND COOK WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
AS REPORTED VIA A POST-MARKET CLINICAL FOLLOW-UP (PMCF) STUDY, AN UNKNOWN BENTSON WIRE WAS USED DURING A PROCEDURE INVOLVING TREATMENT OF A JUXTA-RENAL (NECK LESS THAN TEN MILLIMETERS) DEGENERATIVE ABDOMINAL AORTIC ANEURYSM, WHICH HAD NOT GROWN MORE THAN ONE CENTIMETER PER YEAR. THE PROCEDURE WAS PERFORMED 04JUN2024, USING GENERAL ANESTHESIA AND NEAR-INFRARED SPECTROSCOPY NEUROMONITORING. PERCUTANEOUS ACCESS WAS OBTAINED IN THE LEFT FEMORAL ARTERY AND CUT-DOWN ACCESS WAS OBTAINED IN THE RIGHT FEMORAL AND RIGHT AXILLARY ARTERIES. AN ILIAC ENDOVASCULAR CONDUIT WAS PERFORMED. AFTER ARTERIES WERE REVASCULARIZED WITH PLACEMENT OF A CUSTOM-MADE, FENESTRATED STENT GRAFT, SIDE-BRANCHES WERE CATHETERIZED AND OTHER MANUFACTURERS¿ BRIDGING STENTS WERE PLACED. ANOTHER MANUFACTURER¿S 7X27-MILLIMETER STENT WAS SUCCESSFULLY PLACED IN THE SUPERIOR MESENTERIC ARTERY. ANOTHER MANUFACTURER¿S 5X28-MILLIMETER STENT WAS PLACED IN THE RIGHT RENAL ARTERY, AND A 6X22-MILLIMETER STENT WAS PLACED IN THE LEFT RENAL ARTERY. ALL BRIDGING STENTS-MAINTAINED PATENCY WITH NORMAL END-ARTERY PERFUSION. THERE WERE NO TECHNICAL DIFFICULTIES IN THE SUCCESSFUL DELIVERY AND DEPLOYMENT OF THE CUSTOM-MADE DEVICE. A COOK DISTAL BODY ENDOVASCULAR GRAFT WAS ALSO SUCCESSFULLY PLACED DURING THE PROCEDURE. ESTIMATED BLOOD LOSS DURING THE PROCEDURE WAS 900-MILLILITERS. THE PATIENT DID NOT HAVE ANY SIGNIFICANT MEDICAL PROBLEMS OR COMPLICATIONS DURING THE ORIGINAL PROCEDURE. A POST-PROCEDURAL ANGIOGRAM, PERFORMED THE SAME DAY AS THE ORIGINAL PROCEDURE, SHOWED PATENCY OF ALL TARGET VESSELS AND STENTS. NO ENDOLEAK WAS NOTED. ALL SIDE-BRANCH STENTS WERE INTACT, AND THERE WERE NO ISSUES WITH STENT GRAFT INTEGRITY. NINE DAYS AFTER THE ORIGINAL PROCEDURE, DISSECTION OF THE SUPERIOR MESENTERIC AND RIGHT RENAL ARTERIES WAS NOTED. THE RIGHT RENAL ARTERY (RRA) DISSECTION DID NOT LIMIT FLOW AND NO INTERVENTION WAS REQUIRED. THE SUPERIOR MESENTERIC ARTERY (SMA) DISSECTION WAS SUCCESSFULLY TREATED PERCUTANEOUSLY WITH PLACEMENT OF AN ENDOVASCULAR COVERED STENT WITHIN THE SMA, NINE DAYS AFTER THE ORIGINAL PROCEDURE. PER THE REPORTER, IT IS POSSIBLE THAT AN UNKNOWN COOK BENTSON WIRE, USED DURING CATHETERIZATION OF THE ARTERIES, CONTRIBUTED TO THE DISSECTIONS; HOWEVER, THERE HAS BEEN NO ALLEGED MALFUNCTION OF THE WIRE. PER THE REPORTER, THE EVENT DID NOT OCCUR DUE TO A DEVICE DEFICIENCY. THE REPORTER ALSO STATED THAT IT IS POSSIBLE THAT THE TREATED DISEASE CONTRIBUTED TO THE EVENT, NOTING THAT ¿POST ANEURYSM DISSECTIONS ARE FREQUENTLY SEEN.¿ THE PATIENT RECOVERED WITHOUT FURTHER ISSUE.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 785277 | UNKNOWN | DQX WIRE, GUIDE, CATHETER | DQX | COOK INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Female | Required Intervention | BEGRAFT 5X28MM STENT AND 6X22MM STENT| CMD AC1158261| ICOVER 7X27MM STENT| ZENITH UNIBODY 22-81, A1154387 |