STENT - VASCULAR RECONSTRUCTION
Report
- Report Number
- 3008114965-2021-00652
- Event Type
- Injury
- Date Received
- December 9, 2021
- Date of Event
- May 1, 2015
- Report Date
- December 9, 2021
- Manufacturer
- MEDOS INTERNATIONAL SARL
- Product Code
- NJE
- PMA / PMN Number
- H60001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(B)(4). THIS COMPLAINT IS FROM A LITERATURE SOURCE AND THE FOLLOWING CITATION WAS REVIEWED: JIMENEZ-GOMEZ E, SÁNCHEZ AC, FERNÁNDEZ RO, ALVARADO SV, BRAVO-RODRIGUEZ F, ACOSTA FD. UNPROTECTED CAROTID ARTERY STENTING IN SYMPTOMATIC ELDERLY PATIENTS: A SINGLE-CENTER EXPERIENCE. J NEUROINTERV SURG. 2015 MAY;7(5):341-5. DOI: 10.1136/NEURINTSURG-2014-011131. EPUB 2014 APR 12. PMID: 24727129. THE PRODUCT CATALOG AND LOT NUMBERS ARE NOT AVAILABLE / NOT REPORTED. THE UNIQUE IDENTIFIER (UDI) AND EXPIRATION DATE OF THE DEVICE IS NOT KNOWN. THE INITIAL REPORTER PHONE IS NOT AVAILABLE. THE DEVICE MANUFACTURE DATE IS NOT KNOWN AS THE DEVICE LOT NUMBER IS NOT AVAILABLE / NOT REPORTED. DUE TO THE NATURE OF THE COMPLAINT, THE DEVICE (S) WERE NOT RETURNED FOR ANALYSIS NOR WAS THE STERILE LOT NUMBERS PROVIDED IN ORDER TO CONDUCT A LOT HISTORY REVIEW. AS A RESULT, WE ARE CLOSING THIS INVESTIGATION. IF THE COMPLAINT DEVICE IS RECEIVED IN THE FUTURE, WE WILL REOPEN THE COMPLAINT AND PERFORM THE INVESTIGATION AS APPROPRIATE. THE ARTICLE DOES NOT REPORT ANY DEVICE MALFUNCTIONS OR DEFECTS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.
THIS COMPLAINT IS FROM A LITERATURE SOURCE AND THE FOLLOWING CITATION WAS REVIEWED: JIMENEZ-GOMEZ E, SÁNCHEZ AC, FERNÁNDEZ RO, ALVARADO SV, BRAVO-RODRIGUEZ F, ACOSTA FD. UNPROTECTED CAROTID ARTERY STENTING IN SYMPTOMATIC ELDERLY PATIENTS: A SINGLE-CENTER EXPERIENCE. J NEUROINTERV SURG. 2015 MAY;7(5):341-5. DOI: 10.1136/NEURINTSURG-2014-011131. EPUB 2014 APR 12. PMID: 24727129. OBJECTIVE AND METHODS: AIM IS TO SHOW THE SAFETY AND EFFICACY OF CAROTID STENTING WITHOUT ANY PROTECTION DEVICE IN THESE PATIENTS. ALL PATIENTS OLDER THAN 75 YEARS WITH CAROTID STENOSIS TREATED IN THE CENTER BETWEEN JANUARY 2002 AND DECEMBER 2012 WERE INCLUDED IN THIS PROSPECTIVE STUDY. ALL WERE TREATED BY CAROTID STENTING WITHOUT PROTECTION DEVICES. ANGIOGRAPHIC RESULTS, NEUROLOGIC COMPLICATIONS AND DOPPLER ULTRASOUND WERE COLLECTED DURING THE PROCEDURE AND WITHIN 30 DAYS. 49 PATIENTS WERE INCLUDED (MEAN AGE 78.2 YEARS, RANGE 75¿86). THE AVERAGE DEGREE OF STENOSIS WAS 88.2%. DURING THE PROCEDURE THERE WERE TWO CASES OF TRANSIENT ISCHEMIC ATTACK AND ONE INTRAPARENCHYMAL HEMORRHAGE. THE ARTICLE REPORTS MULTIPLE MANUFACTURER STENTS WERE UTILIZED BUT ONLY ONE OF THE STENTS WERE ENTERPRISE STENT. THE ARTICLE DOES NOT CLARIFY WHICH MANUFACTURER'S STENTS ARE ASSOCIATED WITH THE ADVERSE EVENTS. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED CERENOVUS DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: ENTERPRISE STENT. OTHER CERENOVUS DEVICES THAT WERE ALSO USED IN THIS STUDY: N/A NON-CERENOVUS DEVICES THAT WERE ALSO USED IN THIS STUDY: CAROTID WALSTENT STENT, PRECISE STENTS. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS: QTY 5 BRADYCARDIA RELATED TO CAROTID SINUS STIMULATION (NO INTERVENTIONS ARE DISCUSSED). QTY 2 TRANSIENT ISCHEMIC ATTACKS (NO INTERVENTIONS ARE DISCUSSED). QTY 1 INTRACRANIAL HEMORRHAGE (NO INTERVENTIONS ARE DISCUSSED).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1867039 | STENT - VASCULAR RECONSTRUCTION | INTRACRANIAL NEUROVASCULAR STENT | NJE | MEDOS INTERNATIONAL SARL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Life Threatening |