LEAD EXTRACTION BYRD POLYPROPYLENE DILATOR SHEATH SET
Report
- Report Number
- 2522007-2024-00006
- Event Type
- Death
- Date Received
- March 11, 2024
- Date of Event
- February 14, 2024
- Report Date
- August 28, 2024
- Manufacturer
- COOK VANDERGRIFT INC
- Product Code
- GCC
- PMA / PMN Number
- K893480
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PL
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE DEVICE WAS NOT RETURNED FOR THE COMPLAINT; THEREFORE, A PHYSICAL INVESTIGATION COULD NOT BE PERFORMED, AND THE CUSTOMER'S COMPLAINT COULD NOT BE CONFIRMED, OTHER THAN BY THE CUSTOMER'S TESTIMONY. THE COMPLAINT/EVENT THAT WAS ENTERED AND REPORTED WITHIN TRACKWISE: "DEATH." PER LITERATURE, IT WAS STATED THAT THERE WERE "THREE PROCEDURAL DEATHS." THE DEVICE HISTORY RECORD (DHR) WAS UNABLE TO BE VIEWED DUE TO THE LOT NUMBER SPECIFIC TO THIS COMPLAINT WAS UNKNOWN. THIS COMPLAINT MODE IS BEING MONITORED, TRACKED AND TRENDED PER THE CVI POST MARKET SURVEILLANCE AND COMPLAINT HANDLING PROCESSES. A RISK ASSESSMENT WILL BE PERFORMED AND DOCUMENTED IN THE COMPLAINT SUMMARY TAB IN TRACKWISE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
CORRECTED/UPDATED DATA 28AUG2024 AHE PER THE FOLLOWING D4 - UDI: UDI INFORMATION PER 21CFR 803.52(C)(4) AND 21 CFR 803.50(B) THAT IS REQUIRED IS REASONABLY UNKNOWN DUE TO THE DEVICE ITSELF WAS DISCARDED/NOT RETURNED FOR INVESTIGATION DUE TO SOURCE OF COMPLAINT IS A LITERATURE ARTICLE AND THE LOT OF THE DEVICE WAS UNKNOWN HAS BEEN ADDED/UPDATED TO THIS REPORT: D4 MODEL: UNKNOWN AND G4 - PMA/510(K)#: K893480. THE DEVICE WAS NOT RETURNED FOR THE COMPLAINT; THEREFORE, A PHYSICAL INVESTIGATION COULD NOT BE PERFORMED, AND THE CUSTOMER'S COMPLAINT COULD NOT BE CONFIRMED, OTHER THAN BY THE CUSTOMER'S TESTIMONY. THE COMPLAINT/EVENT THAT WAS ENTERED AND REPORTED WITHIN TRACKWISE: "DEATH." PER LITERATURE, IT WAS STATED THAT THERE WERE "(B)(4) PROCEDURAL DEATHS." THE DEVICE HISTORY RECORD (DHR) WAS UNABLE TO BE VIEWED DUE TO THE LOT NUMBER SPECIFIC TO THIS COMPLAINT WAS UNKNOWN. THIS COMPLAINT MODE IS BEING MONITORED, TRACKED AND TRENDED PER THE CVI POST MARKET SURVEILLANCE AND COMPLAINT HANDLING PROCESSES. A RISK ASSESSMENT WILL BE PERFORMED AND DOCUMENTED IN THE COMPLAINT SUMMARY TAB IN TRACKWISE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE OR UPON COMPLETION OF INVESTIGATION. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
LITERATURE - THE REGISTRY ENROLLED 504 PATIENTS (MEAN AGE 66.6 6 12.8 YEARS; 65.7% MALE). COMPLETE PROCEDURAL SUCCESS WAS ACHIEVED IN 474 PATIENTS (94.0%) AND CLINICAL SUCCESS IN 492 PATIENTS (97.6%). THE TOTAL NUMBER OF MAJOR AND MINOR COMPLICATIONS WAS 16 (3.2%) AND 51 (10%), RESPECTIVELY. THREE PATIENTS (0.6%) DIED DURING THE PROCEDURE. NEW YORK HEART ASSOCIATION FUNCTIONAL CLASS IV AND C-REACTIVE PROTEIN LEVELS DEFINED BEFORE THE PROCEDURE WERE INDEPENDENT PREDICTORS OF ANY MAJOR COMPLICATION, INCLUDING DEATH IN 30 DAYS IN CIED INFECTION PATIENTS. THE TIME SINCE THE LAST PRECEDING PROCEDURE AND PLATELET COUNT BEFORE THE PROCEDURE WERE INDEPENDENT PREDICTORS OF ANY MAJOR COMPLICATION, INCLUDING DEATH IN 30 DAYS IN NON¿CIED INFECTION PATIENTS. LITERATURE - COMPLETE PROCEDURAL SUCCESS WAS ACHIEVED IN 474 PATIENTS (94.0%) AND CLINICAL SUCCESS IN 492 (97.6%). ALL TARGETED LEADS WERE EXTRACTED IN 478 PATIENTS (94.8%). IN 14 PATIENTS (2.8%), A SMALL PART OF THE LEAD (<4 CM) WAS LEFT IN PLACE. FAILURE OF THE PROCEDURE OCCURRED IN 30 PATIENTS (6.0%). THE CRUCIAL CAUSE OF PROCEDURAL AND CLINICAL FAILURE WAS THE PRESENCE OF LEAD FRAGMENTS (>4 CM) IN 12 PATIENTS (2.4%). THERE WERE SIGNIFICANT DIFFERENCES BETWEEN CIED INFECTION AND NON¿CIED INFECTION PATIENTS IN ACHIEVING CLINICAL SUCCESS (99.3% VS 96.6%; P 5 .02) AND COMPLETE PROCEDURAL SUCCESS (97.4% VS 92.6%; P 5 .04). THREE PATIENTS FROM THE CIED INFECTION GROUP UNDERWENT GLADYSZ-WA_NHA ET AL LEAD EXTRACTION IN PATIENTS WITH AND WITHOUT INFECTIONS 3 INCOMPLETE LEAD EXTRACTION (<4 CM OF THE LEAD LEFT IN PLACE), WHICH HAD NO NEGATIVE IMPACT ON THE COURSE OF THE INFECTION (FIGURE 2). THE MOST FREQUENT MINOR COMPLICATION WAS VENOUS THROMBOSIS IN 19 PATIENTS (3.8%), WHICH OCCURRED SIGNIFICANTLY MORE OFTEN IN NON¿CIED INFECTION PATIENTS (5.1% VS 0.7%; P 5 .02). FOUR CASES OF PERICARDIAL EFFUSION WITH NO NEED FOR INTERVENTION OCCURRED IN NON¿CIED INFECTION PATIENTS AND NONE IN THE CIED INFECTION GROUP. TWELVE PATIENTS DIED UP TO 30 DAYS AFTER THE PROCEDURE, 10 IN THE CIED INFECTION GROUP AND 2 IN NON¿CIED INFECTION (P 5 .0001). TWO PATIENTS WITH NON¿CIED INFECTION INDICATIONS FOR TLE WITH RIGHT VENTRICULAR LEAD DYSFUNCTION RESULTING IN ABNORMALITIES OF IMPEDANCE AND CAPTURE AND 1 PATIENTS WITH ISOLATED POCKET EROSION WITH PURULENT DRAINAGE DIED DURING THE PROCEDURE BECAUSE OF SUPERIOR VENA CAVA INJURY (N 5 3 [0.6%]). THE DWELL TIME OF THOSE EXTRACTED LEADS WAS >10YEARS. NINE PATIENTS (1.8%) DIED UP TO 30 DAYS AFTER THE PROCEDURE BECAUSE OF POSTOPERATIVE MANAGEMENT ISSUES OF UNDERLYING DISEASES (EG, SEPSIS OR HEART FAILURE). THE MOST FREQUENT MAJOR COMPLICATION, EXCLUDING DEATH, WAS PERICARDIAL EFFUSION REQUIRING OPEN HEART SURGERY IN 10 PATIENTS. THE FREQUENCY OF OCCURRENCE DID NOT DIFFER BETWEEN THE 2 GROUPS (P 5 .16) (TABLE 4).
LITERATURE - THE REGISTRY ENROLLED (B)(4)). COMPLETE PROCEDURAL SUCCESS WAS ACHIEVED IN (B)(4) AND CLINICAL SUCCESS IN (B)(4). THE TOTAL NUMBER OF MAJOR AND MINOR COMPLICATIONS WAS (B)(4), RESPECTIVELY. (B)(4) DIED DURING THE PROCEDURE. NEW YORK HEART ASSOCIATION FUNCTIONAL CLASS IV AND C-REACTIVE PROTEIN LEVELS DEFINED BEFORE THE PROCEDURE WERE INDEPENDENT PREDICTORS OF ANY MAJOR COMPLICATION, INCLUDING DEATH IN 30 DAYS IN CIED INFECTION PATIENTS. THE TIME SINCE THE LAST PRECEDING PROCEDURE AND PLATELET COUNT BEFORE THE PROCEDURE WERE INDEPENDENT PREDICTORS OF ANY MAJOR COMPLICATION, INCLUDING DEATH IN 30 DAYS IN NON¿CIED INFECTION PATIENTS. LITERATURE - COMPLETE PROCEDURAL SUCCESS WAS ACHIEVED IN (B)(4) AND CLINICAL SUCCESS IN (B)(4). ALL TARGETED LEADS WERE EXTRACTED IN (B)(4). IN (B)(4)), A SMALL PART OF THE LEAD (<4 CM) WAS LEFT IN PLACE. FAILURE OF THE PROCEDURE OCCURRED IN 30 PATIENTS (6.0%). THE CRUCIAL CAUSE OF PROCEDURAL AND CLINICAL FAILURE WAS THE PRESENCE OF LEAD FRAGMENTS (>4 CM) IN (B)(4). THERE WERE SIGNIFICANT DIFFERENCES BETWEEN CIED INFECTION AND NON¿CIED INFECTION PATIENTS IN ACHIEVING CLINICAL SUCCESS (B)(4) AND COMPLETE PROCEDURAL SUCCESS (B)(4). (B)(4) PATIENTS FROM THE CIED INFECTION GROUP UNDERWENT GLADYSZ-WA_NHA ET AL LEAD EXTRACTION IN PATIENTS WITH AND WITHOUT INFECTIONS (B)(4) INCOMPLETE LEAD EXTRACTION (<4 CM OF THE LEAD LEFT IN PLACE), WHICH HAD NO NEGATIVE IMPACT ON THE COURSE OF THE INFECTION (FIGURE 2). THE MOST FREQUENT MINOR COMPLICATION WAS VENOUS THROMBOSIS IN (B)(4), WHICH OCCURRED SIGNIFICANTLY MORE OFTEN IN NON¿CIED INFECTION PATIENTS ((B)(4)). (B)(4) CASES OF PERICARDIAL EFFUSION WITH NO NEED FOR INTERVENTION OCCURRED IN NON¿CIED INFECTION PATIENTS AND NONE IN THE CIED INFECTION GROUP. (B)(4) PATIENTS DIED UP TO 30 DAYS AFTER THE PROCEDURE, (B)(4) IN THE CIED INFECTION GROUP AND (B)(4) IN NON¿CIED INFECTION ((B)(4)). (B)(4) PATIENTS WITH NON¿CIED INFECTION INDICATIONS FOR TLE WITH RIGHT VENTRICULAR LEAD DYSFUNCTION RESULTING IN ABNORMALITIES OF IMPEDANCE AND CAPTURE AND 1 PATIENTS WITH ISOLATED POCKET EROSION WITH PURULENT DRAINAGE DIED DURING THE PROCEDURE BECAUSE OF SUPERIOR VENA CAVA INJURY ((B)(4)). THE DWELL TIME OF THOSE EXTRACTED LEADS WAS >10YEARS. (B)(4) DIED UP TO 30 DAYS AFTER THE PROCEDURE BECAUSE OF POSTOPERATIVE MANAGEMENT ISSUES OF UNDERLYING DISEASES (EG, SEPSIS OR HEART FAILURE). THE MOST FREQUENT MAJOR COMPLICATION, EXCLUDING DEATH, WAS PERICARDIAL EFFUSION REQUIRING OPEN HEART SURGERY IN (B)(4) PATIENTS. THE FREQUENCY OF OCCURRENCE DID NOT DIFFER BETWEEN THE (B)(4) (TABLE 4).
LITERATURE - THE REGISTRY ENROLLED 504 PATIENTS (MEAN AGE 66.6 6 12.8 YEARS; 65.7% MALE). COMPLETE PROCEDURAL SUCCESS WAS ACHIEVED IN 474 PATIENTS (94.0%) AND CLINICAL SUCCESS IN 492 PATIENTS (97.6%). THE TOTAL NUMBER OF MAJOR AND MINOR COMPLICATIONS WAS 16 (3.2%) AND 51 (10%), RESPECTIVELY. THREE PATIENTS (0.6%) DIED DURING THE PROCEDURE. NEW YORK HEART ASSOCIATION FUNCTIONAL CLASS IV AND C-REACTIVE PROTEIN LEVELS DEFINED BEFORE THE PROCEDURE WERE INDEPENDENT PREDICTORS OF ANY MAJOR COMPLICATION, INCLUDING DEATH IN 30 DAYS IN CIED INFECTION PATIENTS. THE TIME SINCE THE LAST PRECEDING PROCEDURE AND PLATELET COUNT BEFORE THE PROCEDURE WERE INDEPENDENT PREDICTORS OF ANY MAJOR COMPLICATION, INCLUDING DEATH IN 30 DAYS IN NON¿CIED INFECTION PATIENTS. LITERATURE - COMPLETE PROCEDURAL SUCCESS WAS ACHIEVED IN 474 PATIENTS (94.0%) AND CLINICAL SUCCESS IN 492 (97.6%). ALL TARGETED LEADS WERE EXTRACTED IN 478 PATIENTS (94.8%). IN 14 PATIENTS (2.8%), A SMALL PART OF THE LEAD (<4 CM) WAS LEFT IN PLACE. FAILURE OF THE PROCEDURE OCCURRED IN 30 PATIENTS (6.0%). THE CRUCIAL CAUSE OF PROCEDURAL AND CLINICAL FAILURE WAS THE PRESENCE OF LEAD FRAGMENTS (>4 CM) IN 12 PATIENTS (2.4%). THERE WERE SIGNIFICANT DIFFERENCES BETWEEN CIED INFECTION AND NON¿CIED INFECTION PATIENTS IN ACHIEVING CLINICAL SUCCESS (99.3% VS 96.6%; P 5 .02) AND COMPLETE PROCEDURAL SUCCESS (97.4% VS 92.6%; P 5 .04). THREE PATIENTS FROM THE CIED INFECTION GROUP UNDERWENT GLADYSZ-WA_NHA ET AL LEAD EXTRACTION IN PATIENTS WITH AND WITHOUT INFECTIONS 3 INCOMPLETE LEAD EXTRACTION (<4 CM OF THE LEAD LEFT IN PLACE), WHICH HAD NO NEGATIVE IMPACT ON THE COURSE OF THE INFECTION (FIGURE 2). THE MOST FREQUENT MINOR COMPLICATION WAS VENOUS THROMBOSIS IN 19 PATIENTS (3.8%), WHICH OCCURRED SIGNIFICANTLY MORE OFTEN IN NON¿CIED INFECTION PATIENTS (5.1% VS 0.7%; P 5 .02). FOUR CASES OF PERICARDIAL EFFUSION WITH NO NEED FOR INTERVENTION OCCURRED IN NON¿CIED INFECTION PATIENTS AND NONE IN THE CIED INFECTION GROUP. TWELVE PATIENTS DIED UP TO 30 DAYS AFTER THE PROCEDURE, 10 IN THE CIED INFECTION GROUP AND 2 IN NON¿CIED INFECTION (P 5 .0001). TWO PATIENTS WITH NON¿CIED INFECTION INDICATIONS FOR TLE WITH RIGHT VENTRICULAR LEAD DYSFUNCTION RESULTING IN ABNORMALITIES OF IMPEDANCE AND CAPTURE AND 1 PATIENTS WITH ISOLATED POCKET EROSION WITH PURULENT DRAINAGE DIED DURING THE PROCEDURE BECAUSE OF SUPERIOR VENA CAVA INJURY (N 5 3 [0.6%]). THE DWELL TIME OF THOSE EXTRACTED LEADS WAS >10 YEARS. NINE PATIENTS (1.8%) DIED UP TO 30 DAYS AFTER THE PROCEDURE BECAUSE OF POSTOPERATIVE MANAGEMENT ISSUES OF UNDERLYING DISEASES (EG, SEPSIS OR HEART FAILURE). THE MOST FREQUENT MAJOR COMPLICATION, EXCLUDING DEATH, WAS PERICARDIAL EFFUSION REQUIRING OPEN HEART SURGERY IN 10 PATIENTS. THE FREQUENCY OF OCCURRENCE DID NOT DIFFER BETWEEN THE 2 GROUPS (P 5 .16) (TABLE 4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2457480 | LEAD EXTRACTION BYRD POLYPROPYLENE DILATOR SHEATH SET | GCC DILATOR, CATHETER | GCC | COOK VANDERGRIFT INC | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Death |