UNKPROWLERSELECT
Report
- Report Number
- 1226348-2021-00087
- Event Type
- Injury
- Date Received
- October 5, 2021
- Date of Event
- July 1, 2021
- Report Date
- October 5, 2021
- Manufacturer
- CODMAN AND SHURTLEFF, INC
- Product Code
- KRA
- PMA / PMN Number
- K021591
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
PRODUCT COMPLAINT # (B)(4). "LITERATURE ARTICLE ¿FLOW DIVERSION FOR RECONSTRUCTION OF INTRADURAL VERTEBRAL ARTERY DISSECTING ANEURYSMS CAUSING SUBARACHNOID HEMORRHAGE-A RETROSPECTIVE STUDY FROM FOUR NEUROVASCULAR CENTERS¿ REVIEWED. MAYBAUM J, HENKES H, AGUILAR-PÉREZ M, HELLSTERN V, GIHR GA, HÄRTIG W, REISBERG A, MUCHA D, SCHÜNGEL MS, BRILL R, QUÄSCHLING U, HOFFMANN KT, SCHOB S. FRONT NEUROL. 2021 JUL 1;12:700164. DOI: 10.3389/FNEUR.2021.700164. PMID: 34276549; PMCID: PMC8280292. THE ARTICLE CANNOT BE ATTACHED TO DUE ELECTRONIC FILE SIZE. NO DEVICE WAS RECEIVED FOR ANALYSIS AT THE TIME OF SUBMISSION OF THE INITIAL 3500A. SINCE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED, AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS PROVIDED BY THE CUSTOMER. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 4. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY CERENOVUS, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, CERENOVUS, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. 6. HEALTH EFFECT - CLINICAL CODE SHOULD ONLY BE ISCHEMIA STROKE (E013302) AND RUPTURED ANEURYSM (E050101).
PRODUCT COMPLAINT # (B)(4). "LITERATURE ARTICLE ¿FLOW DIVERSION FOR RECONSTRUCTION OF INTRADURAL VERTEBRAL ARTERY DISSECTING ANEURYSMS CAUSING SUBARACHNOID HEMORRHAGE-A RETROSPECTIVE STUDY FROM FOUR NEUROVASCULAR CENTERS¿ REVIEWED. MAYBAUM J, HENKES H, AGUILAR-PÉREZ M, HELLSTERN V, GIHR GA, HÄRTIG W, REISBERG A, MUCHA D, SCHÜNGEL MS, BRILL R, QUÄSCHLING U, HOFFMANN KT, SCHOB S. FRONT NEUROL. 2021 JUL 1;12:700164. DOI: 10.3389/FNEUR.2021.700164. PMID: 34276549; PMCID: PMC8280292. NO DEVICE WAS RECEIVED FOR ANALYSIS AT THE TIME OF SUBMISSION OF THE INITIAL 3500A. SINCE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED, AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS PROVIDED BY THE CUSTOMER. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.
"LITERATURE ARTICLE ¿FLOW DIVERSION FOR RECONSTRUCTION OF INTRADURAL VERTEBRAL ARTERY DISSECTING ANEURYSMS CAUSING SUBARACHNOID HEMORRHAGE-A RETROSPECTIVE STUDY FROM FOUR NEUROVASCULAR CENTERS¿ REVIEWED. MAYBAUM J, HENKES H, AGUILAR-PÉREZ M, HELLSTERN V, GIHR GA, HÄRTIG W, REISBERG A, MUCHA D, SCHÜNGEL MS, BRILL R, QUÄSCHLING U, HOFFMANN KT, SCHOB S. FRONT NEUROL. 2021 JUL 1;12:700164. DOI: 10.3389/FNEUR.2021.700164. PMID: 34276549; PMCID: PMC8280292. OBJECTIVE AND METHODS: THIS ARTICLE IS A RETROSPECTIVE STUDY OF MULTICENTER DATA REGARDING THE RECONSTRUCTIVE APPROACH WITH FLOW-DIVERTING STENTS TO TREAT RUPTURED DISSECTING ANEURYSMS OF THE VERTEBROBASILAR SYSTEM. THIRTY-ONE PATIENTS (17 MALE AND 14 FEMALE) BETWEEN 30 AND 78 YEARS WHO HAD SUFFERED FROM SAH CAUSED BY THE RUPTURE OF A DISSECTING ANEURYSM OF THE DOMINANT INTRADURAL VA WERE INCLUDED. OF THOSE, 11 HAD THE DISSECTING ANEURYSM AT THE RIGHT HAND SIDE DOMINANT VA, WHILE THE REMAINING PATIENTS HAD THE DISSECTING ANEURYSM AT THE LEFT-HAND SIDE DOMINANT VA. IN SIX PATIENTS, THE DISSECTING ANEURYSM MORPHOLOGICALLY INVOLVED THE BASILAR ARTERY. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED CERENOVUS DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: 11×6F ENVOY MP CERENOVUS AND PROWLER SELECT PLUS CERENOVUS OTHER CERENOVUS DEVICES THAT WERE ALSO USED IN THIS STUDY: N/A NON-CERENOVUS DEVICES THAT WERE ALSO USED IN THIS STUDY: DISTAL ACCESS CATHETER 11× 6F SOFIA, MICROVENTION 8× 6F HEARTRAIL II, TERUMO EUROPE GUIDING CATHETER 13× 6F NEURON MAX PENUMBRA 7× 6F GUIDER SOFTTIP BOSTON SCIENTIFIC PIPELINE EMBOLIZATION DEVICE MEDTRONIC PHENOM 27 MEDTRONIC P64 FLOW MODULATION DEVICE PHENOX EXCELSIOR XT 27 STRYKER REBAR 18 MEDTRONIC THE SILK+ BALT EXTRUSION VASCO 25 BALT EXTRUSION P48MW PHENOX SILK VISTA BABY BALT EXTRUSION HEADWAY 17 MICROVENTION N-BUTYL CYANOACRYLATE HISTOACRYL, ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS: (3) ISCHEMIC STROKE (2) CEREBRAL INFARCTION (1) PERIPROCEDURAL RE-RUPTURE OF THE DISSECTING ANEURYSM WITH SALVAGE EMBOLIZATION WITH N-BUTYL CYANOACRYLATE (1) CEREBELLAR HEMORRHAGE (7) PERMANENT INJURY / DISABILITY
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1473595 | UNKPROWLERSELECT | CATHETER, CONTINUOUS FLUSH | KRA | CODMAN AND SHURTLEFF, INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Life Threatening | 7× 6F GUIDER SOFTTIP BOSTON SCIENTIFIC| 8× 6F HEARTRAIL II, TERUMO EUROPE| DISTAL ACCESS CATHETER 11× 6F SOFIA, MICROVENTION| EXCELSIOR XT 27 STRYKER| GUIDING CATHETER 13× 6F NEURON MAX PENUMBRA| HEADWAY 17 MICROVENTION| N-BUTYL CYANOACRYLATE HISTOACRYL| P48MW PHENOX| P64 FLOW MODULATION DEVICE PHENOX| PHENOM 27 MEDTRONIC| PIPELINE EMBOLIZATION DEVICE MEDTRONIC| REBAR 18 MEDTRONIC| SILK VISTA BABY BALT EXTRUSION| THE SILK+ BALT EXTRUSION| VASCO 25 BALT EXTRUSION |