ENROUTE NEUROPROTECTION SYSTEM
Report
- Report Number
- 3014526664-2021-00054
- Event Type
- Death
- Date Received
- April 28, 2021
- Date of Event
- April 1, 2021
- Report Date
- March 8, 2023
- Manufacturer
- SILK ROAD MEDICAL
- Product Code
- NTE
- UDI-DI
- 00811311020829
- PMA / PMN Number
- K153485
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
ADDITIONAL/UPDATED INFORMATION CAN BE FOUND IN THE FOLLOWING FIELDS: OUTCOMES ATTRIBUTED TO ADVERSE EVENT. DATE OF THIS REPORT. DATE RECEIVED BY MANUFACTURER. TYPE OF REPORT. TYPE OF REPORTABLE EVENT. IF FOLLOW UP, WHAT TYPE? ADVERSE EVENT PROBLEM. ON 06/22/2021, SILK ROAD MEDICAL INC. RECEIVED ADDITIONAL INFORMATION FROM THE HOSPITAL'S SENIOR MEDICAL PARTNER, DR. (B)(6), WHO STATED THAT THIS PATIENT EXPIRED. THE PATIENT DEATH DATE WAS NOT PROVIDED TO US AS THE SURGEON DID NOT HAVE CONTACT WITH THE FAMILY SINCE THE PATIENT WAS TRANSFERRED TO A LONG TERM CARE FACILITY. THIS EVENT IS BELIEVED TO BE RELATED TO THE HEMORRHAGE STROKE REPORTED ON FOLLOW-UP #1 (SUBMITTED 18-JUN-2021). A HEMORRHAGE STROKE IS NOT UNIQUE TO TCAR AND CAN OCCUR WITH ANY CAROTID PROCEDURE. BASED ON THIS ADDITIONAL INFORMATION, IT WAS DETERMINED THAT THERE IS NO EVIDENCE THAT A SILK ROAD MEDICAL DEVICE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT OR THAT A MALFUNCTION OCCURRED.
THE FOLLOWING FIELDS WERE UPDATED BASED ON THE SUBMISSION OF THIS REPORT: B4: DATE OF THIS REPORT, G3: DATE RECEIVED BY MANUFACTURER, G6: TYPE OF REPORT; FOLLOW-UP NUMBER, H2: IF FOLLOW-UP, WHAT TYPE? H10/H11: MANUFACTURER NARRATIVE/CORRECTED DATA: A HEMORRHAGE STROKE IS NOT UNIQUE TO TCAR AND CAN OCCUR WITH ANY CAROTID PROCEDURE. BASED ON THE ADDITIONAL INFORMATION RECEIVED ON 06/08/2021, IT WAS DETERMINED THAT THERE IS NO EVIDENCE THAT A SILK ROAD MEDICAL DEVICE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT OR THAT A MALFUNCTION OCCURRED. THIS FOLLOW-UP MDR IS BEING SUBMITTED TO INDICATE THAT THE INITIAL MDR REPORT IS BEING RETRACTED.
ON (B)(6) 2021, SILK ROAD MEDICAL INC. RECEIVED ADDITIONAL INFORMATION FROM THE HOSPITAL'S SENIOR MEDICAL PARTNER, DR. (B)(6) WHO STATED THAT THIS PATIENT EXPERIENCED A HEMORRHAGIC BLEED AND A CRANIOTOMY WAS PERFORMED. THE PATIENT WAS PLACED IN A LONG TERM CARE FACILITY, HOWEVER, THE PATIENT IS ONLY SHOWING SOME SLIGHT IMPROVEMENTS. A HEMORRHAGE STROKE IS NOT UNIQUE TO TCAR AND CAN OCCUR WITH ANY CAROTID PROCEDURE. BASED ON THIS ADDITIONAL INFORMATION, IT WAS DETERMINED THAT THERE IS NO EVIDENCE THAT A SILK ROAD MEDICAL DEVICE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT OR THAT A MALFUNCTION OCCURRED.
IT WAS REPORTED THAT DURING A TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE ELECTRONEURODIAGNOSTIC TECH NOTIFIED THE PHYSICIAN THAT THE WAVEFORMS HAD DIMINISHED ON THE ELECTROENCEPHALOGRAM (EEG). THE PHYSICIANS OPTED TO ACHIEVE ACCESS AGAIN WITH A MICROPUNCTURE SYSTEM IN THE CAROTID. THE ACCESS WAS OBTAINED AND CEREBRAL ARTERIOGRAMS WERE PERFORMED. THE COMMON AND INTERNAL CAROTIDS WERE PATENT. THE PHYSICIANS STATED THAT THE ANTERIOR PORTION OF THE BRAIN WAS NOT BEING PERFUSED. A RADIOLOGIST WAS THEN CALLED IN TO CONSULT AND THE DECISION WAS MADE TO TRANSPORT THE PATIENT TO A DIFFERENT FACILITY FOR FURTHER INTERVENTION. ON (B)(6) 2021, IT WAS REPORTED THAT THE PATIENT UNDERWENT ADDITIONAL IMAGING OF THE BRAIN AND THE RESULTS CONCLUDED THAT ALL CEREBRAL VESSELS WERE OPEN. NO ADDITIONAL DETAILS ARE KNOWN OF THE PATIENT'S CONDITION OTHER THAN THE FACT THAT HE IS ALIVE.
THIS SUPPLEMENTAL MDR IS BEING SUBMITTED TO CORRECT THE INADVERTENT ENTRY ERROR MADE IN B1 (ADVERSE EVENT OR PRODUCT PROBLEM) AND B2 (OUTCOMES ATTRIBUTED TO ADVERSE EVENT) FOR THE FOLLOW UP REPORTS SUBMITTED ON 06/18/2021 AND 7/7/2021.
IT WAS REPORTED THAT DURING A TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE ELECTRONEURO DIAGNOSTIC TECH NOTIFIED THE PHYSICIAN THAT THE WAVEFORMS HAD DIMINISHED ON THE ELECTROENCEPHALOGRAM (EEG). THE PHYSICIANS OPTED TO ACHIEVE ACCESS AGAIN WITH A MICROPUNCTURE SYSTEM IN THE CAROTID. THE ACCESS WAS OBTAINED AND CEREBRAL ARTERIOGRAMS WERE PERFORMED. THE COMMON AND INTERNAL CAROTIDS WERE PATENT. THE PHYSICIANS STATED THAT THE ANTERIOR PORTION OF THE BRAIN WAS NOT BEING PERFUSED. A RADIOLOGIST WAS THEN CALLED IN TO CONSULT AND THE DECISION WAS MADE TO TRANSPORT THE PATIENT TO A DIFFERENT FACILITY FOR FURTHER INTERVENTION. ON (B)(6) 2021, IT WAS REPORTED THAT THE PATIENT UNDERWENT ADDITIONAL IMAGING OF THE BRAIN AND THE RESULTS CONCLUDED THAT ALL CEREBRAL VESSELS WERE OPEN. NO ADDITIONAL DETAILS ARE KNOWN OF THE PATIENT'S CONDITION OTHER THAN THE FACT THAT HE IS ALIVE.
THE PRODUCT ASSOCIATED WITH THIS COMPLAINT WAS NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS. A REVIEW OF MANUFACTURING RECORDS FOR THIS DEVICE WAS COMPLETED AND NO ISSUES WERE IDENTIFIED THAT COULD HAVE LED TO THE ADVERSE EVENT REPORTED. THERE IS NO INDICATION THAT A MALFUNCTION OF THE SRM DEVICE OCCURRED. THE CAUSE OF THE INTRA-OPERATIVE COMPLICATION IS UNKNOWN. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. SILK ROAD MEDICAL WILL CONTINUE TO MONITOR FOR OCCURRENCES OF SIMILAR EVENTS.
IT WAS REPORTED THAT DURING A TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE ELECTRONEURODIAGNOSTIC TECH NOTIFIED THE PHYSICIAN THAT THE WAVEFORMS HAD DIMINISHED ON THE ELECTROENCEPHALOGRAM (EEG). THE PHYSICIANS OPTED TO ACHIEVE ACCESS AGAIN WITH A MICROPUNCTURE SYSTEM IN THE CAROTID. THE ACCESS WAS OBTAINED AND CEREBRAL ARTERIOGRAMS WERE PERFORMED. THE COMMON AND INTERNAL CAROTIDS WERE PATENT. THE PHYSICIANS STATED THAT THE ANTERIOR PORTION OF THE BRAIN WAS NOT BEING PERFUSED. A RADIOLOGIST WAS THEN CALLED IN TO CONSULT AND THE DECISION WAS MADE TO TRANSPORT THE PATIENT TO A DIFFERENT FACILITY FOR FURTHER INTERVENTION. ON (B)(6) 2021, IT WAS REPORTED THAT THE PATIENT UNDERWENT ADDITIONAL IMAGING OF THE BRAIN AND THE RESULTS CONCLUDED THAT ALL CEREBRAL VESSELS WERE OPEN. NO ADDITIONAL DETAILS ARE KNOWN OF THE PATIENT'S CONDITION OTHER THAN THE FACT THAT HE IS ALIVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 634591 | ENROUTE NEUROPROTECTION SYSTEM | TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE | NTE | SILK ROAD MEDICAL | SR-200-NPS | 301596 | 00811311020829 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Male | Disability| D |