PIPELINE FLEX W/SHIELD TECHNOLOGY
Report
- Report Number
- 2029214-2025-00066
- Event Type
- Death
- Date Received
- January 7, 2025
- Date of Event
- December 6, 2024
- Report Date
- August 13, 2025
- Manufacturer
- MICRO THERAPEUTICS, INC. DBA EV3
- Product Code
- OUT
- UDI-DI
- 00763000284091
- PMA / PMN Number
- P100018
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
CONTINUATION OF D10: PRODUCT ID: PED2-325-20 (B621488). MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
MEDTRONIC RECEIVED INFORMATION REGARDING A PATIENT WHO HAD TWO PIPELINES OF THE SAME MODEL/LOT IMPLANTED WHO HAD POST-OPERATIVE COMPLICATIONS. IT WAS REPORTED THAT THE TWO PIPELINE FLEX WITH SHIELD STENTS WERE IMPLANTED ON (B)(6) 2024. NO DEVICE MALFUNCTION OR INTRAOPERATIVE ISSUE WAS REPORTED. ON (B)(6) 2024, THE PATIENT WAS HOSPITALIZED AFTER EXPERIENCING FEVER AND PROGRESSIVE DECLINE IN MENTAL STATUS. IMAGING RESULTS WERE SUGGESTIVE OF CONCERN FOR CEREBRAL VASOSPASM ASSOCIATED WITH SUBARACHNOID HEMORRHAGE (SAH) IN EVOLUTION. THE PATIENT UNDERWENT A PROCEDURE FOR INTRAARTERIAL VASODILATOR (VERAPAMIL 20MG) INTERNAL CAROTID ARTERY (ICA) INFUSION WITH MILD IMPROVEMENT AND WAS MONITORED. IT WAS CONSIDERED LIKELY THAT VASOSPASM CAUSED THE SYMPTOMS OF FEVER AND SIMILAR SYMPTOMS TO PNEUMONIA AND SEPTIC SHOCK. THE PATIENT OUTCOME WAS NOTED AS "RECOVERING/RESOLVING." THE EVENT REQUIRED PATIENT HOSPITALIZATION AND INTERVENTION BUT WAS NOT LIFE-THREATENING AND DID NOT RESULT IN PATIENT DISABILITY. SITE ASSESSMENT CONCLUDED THE EVENTS WERE POSSIBLE RELATED TO THE PATIENT DISEASE UNDER STUDY AND/OR THE INDEX PROCEDURE BUT NOT RELATED TO THE IMPLANTED PIPELINES OR ACCESSORY DEVICES.
ADDITIONAL INFORMATION RECEIVED REPORTED THE EVENT BECAME FATAL ON (B)(6) 2024. SYMPTOMATIC VASOSPASM PDO 5, 8, DCI ON CT POD 18, DEATH SEVERE ADVERSE EVENT CRITERIA ALTHOUGH NOT IMMEDIATE CAUSE OF DEATH, THE VASOSPASM AND DCI MAY HAVE CONTRIBUTED TO PROLONGED INTUBATION AND ARDS.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE EVENT WAS CAUSALLY RELATED TO THE DISEASE UNDER STUDY. THE SITE WAS QUERIED TO CONFIRM IF MULTIPLE DEVICES WERE USED. AVAILABLE SOURCE DOCUMENT ONLY MENTIONS ONE STUDY DEVICE IMPLANTATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1322204 | PIPELINE FLEX W/SHIELD TECHNOLOGY | INTRACRANIAL ANEURYSM FLOW DIVERTER | OUT | MICRO THERAPEUTICS, INC. DBA EV3 | PED2-325-20 | B621488 | 00763000284091 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Female | Hospitalization| D| R | SEE H11. |