ESOFLIP
Report
- Report Number
- 3006897778-2019-00003
- Event Type
- Death
- Date Received
- March 11, 2019
- Report Date
- June 4, 2019
- Manufacturer
- CROSPON LTD
- Product Code
- PIE
- PMA / PMN Number
- K132337
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
(MODEL#, CATALOG#), MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
ACCORDING TO THE REPORTER, THE PATIENT HAD A MALIGNANT PLEURAL EFFUSION, MALNUTRITION FROM "PSEUDOACHALASIA" AND PERFORATION AFTER DILATION. ON HEART RATE MONITOR (HRM), THEY HAD A PICTURE OF TYPE 2 ACHALASIA WHICH WAS TREATED DURING ESOPHAGOGASTRODUODENOSCOPY (EGD). WHEN THE CATHETER WAS PLACED AND INFLATED, THEY DID NOT SEE ANY ESOPHAGEAL WIDENING SO THEY KEPT INFLATING THE BALLOON AND GOT HIGH PRESSURE ALARMS. DURING RECOVERY, THE PATIENT COMPLAINED OF CHEST PAIN WHICH SHOWED PERFORATION. THE PATIENT DIED AND DURING AUTOPSY, THEY FOUND THE PATIENT TO HAVE A METASTATIC BREAST CANCER THAT CAUSED THE STRICTURE IN THE ESOPHAGUS. IT IS UNKNOWN AT THIS TIME IF THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
ACCORDING TO THE REPORTER, THE PATIENT HAD A MALIGNANT PLEURAL EFFUSION, MALNUTRITION FROM "PSEUDOACHALASIA" AND PERFORATION AFTER DILATION. ON HEART RATE MONITOR (HRM), THEY HAD A PICTURE OF TYPE 2 ACHALASIA WHICH WAS TREATED DURING ESOPHAGOGASTRODUODENOSCOPY (EGD). WHEN THE CATHETER WAS PLACED AND INFLATED, THEY DID NOT SEE ANY ESOPHAGEAL WIDENING SO THEY KEPT INFLATING THE BALLOON AND GOT HIGH PRESSURE ALARMS. DURING RECOVERY, THE PATIENT COMPLAINED OF CHEST PAIN WHICH SHOWED PERFORATION. THE PATIENT DIED AND DURING AUTOPSY, THEY FOUND THE PATIENT TO HAVE A METASTATIC BREAST CANCER THAT CAUSED THE STRICTURE IN THE ESOPHAGUS.
ACCORDING TO THE REPORTER, THE PATIENT HAD A PSEUDOACHALASIA AND PERFORATION AFTER DILATION. THE PATIENT DIED AND DURING AUTOPSY, THEY FOUND THE PATIENT TO HAVE A METASTATIC BREAST CANCER THAT CAUSED THE STRICTURE IN THE ESOPHAGUS. THE PATIENT ALSO HAD A MALIGNANT PLEURAL EFFUSION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 200381 | ESOFLIP | ESOPHAGEAL DILATOR WITH BALLOON AND ELECTRODE SENSORS | PIE | CROSPON LTD | ES-330 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Death |