132CM LARGE BORE 71 CATHETER
Report
- Report Number
- 3008114965-2024-00763
- Event Type
- Injury
- Date Received
- August 1, 2024
- Date of Event
- July 15, 2024
- Report Date
- September 13, 2024
- Manufacturer
- MEDOS INTERNATIONAL SARL
- Product Code
- NRY
- UDI-DI
- 10886704082378
- PMA / PMN Number
- K191237
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
PRODUCT COMPLAINT # (B)(4). THE DEVICE WAS NOT RETURNED, THEREFORE, NO FURTHER INVESTIGATION CAN BE PERFORMED. THE LOT NUMBER IS NOT KNOWN; THEREFORE, A DEVICE HISTORY RECORD REVIEW CANNOT BE COMPLETED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.
PRODUCT COMPLAINT # (B)(4). SECTION D2B: PROCODE IS NRY/QJP. PER THE ADDITIONAL INFORMATION RECEIVED ON 11-SEP-2024, THE EVENT OF ¿RIGHT MCA PETECHIAL HEMORRHAGE¿ WAS CONFIRMED AS BEING ATTRIBUTED TO A REPERFUSION INJURY AND WAS POSSIBLY WORSENED BY THE ANTICOAGULATION MEDICATION THE PATIENT WAS PREVIOUSLY PRESCRIBED FOR ATRIAL FIBRILLATION (XARELTO). A REPERFUSION INJURY OCCURS WHEN BLOOD VESSELS IN THE BRAIN RUPTURE AFTER BLOOD FLOW IS RESTORED FOLLOWING A STROKE. A REPERFUSION INJURY IS NOT A REPORTABLE EVENT SINCE IT IS ATTRIBUTED TO THE PATIENT¿S INDEX STROKE. BASED ON THIS INFORMATION, THE EVENT OF ¿RIGHT MCA PETECHIAL HEMORRHAGE¿ NO LONGER MEETS US FDA REPORTING CRITERIA.
PRODUCT COMPLAINT # (B)(4). SECTION A1. PATIENT IDENTIFIER: (B)(6). SECTION D2B: PROCODE IS NRY/QJP. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. HEMORRHAGE IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH ENDOVASCULAR MECHANICAL THROMBECTOMY FOR ACUTE ISCHEMIC STROKE CASES AND IS LISTED IN THE EMBOVAC INSTRUCTIONS FOR USE (IFU) AS SUCH. THERE WERE NO ALLEGED QUALITY ISSUES RELATED TO THE USED DEVICE, AS THE DEVICE PERFORMED AS INTENDED. PETECHIAL HEMORRHAGES, ALSO KNOWN AS HEMORRHAGIC INFARCTION, IS CLASSIFIED AS A HEMORRHAGIC TRANSFORMATION (HT) SUBTYPE AND IS A FREQUENT SPONTANEOUS COMPLICATION OF ISCHEMIC STROKE. BECAUSE OF DIMINISHED AUTOREGULATION IN VESSELS SUPPLYING THE INFARCTED TISSUES WITH THE INABILITY TO RETAIN BLOOD INSIDE OF THE ARTERIES, THERE IS INCREASED RISK OF HEMORRHAGE UPON RETURN OF NORMAL BLOOD FLOW. A REVIEW OF THE AVAILABLE INFORMATION SUGGESTS THAT PATIENT, PROCEDURAL, AND PHARMACOLOGICAL FACTORS, SUCH AS PROXIMAL MIDDLE CEREBRAL ARTERY OCCLUSION AND DELAYED RECANALIZATION, MAY HAVE CONTRIBUTED TO THE EVENT WITH NO INDICATION OF A DEVICE MALFUNCTION OR PERFORMANCE ISSUE. HOWEVER, SINCE THE INVESTIGATOR FELT THAT THE PETECHIAL HEMORRHAGE WAS POSSIBLY RELATED TO THE EMBOVAC, AND POSSIBLY RELATED TO THE SURGICAL PROCEDURE, THE CORRELATING RELATIONSHIP BETWEEN THE DEVICE AND EVENT CANNOT BE RULED OUT COMPLETELY. ADDITIONALLY, THE PATIENT OUTCOME IS UNKNOWN. BASED ON THIS INFORMATION AND THE ASSESSMENT OF THE PI, THIS EVENT DOES MEET US FDA REPORTING CRITERIA UNDER 21 CFR 803 WITH A CLASSIFICATION OF ¿SERIOUS INJURY.¿ THE FILE WILL BE RE-REVIEWED IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE. AS PART OF THE POST MARKET SURVEILLANCE PROGRAM, INFORMATION FROM THIS COMPLAINT IS TRENDED TO IDENTIFY STATISTICAL SIGNALS FOR CONSIDERATION OF FURTHER CORRECTION ACTION. SINCE THERE WAS NO EVIDENCE TO SUGGEST THE EVENT WAS RELATED TO A MANUFACTURING OR DESIGN ISSUE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. MISSING INFORMATION FROM THIS REPORT IS IDENTIFIED AS BLANK; THIS INFORMATION WAS NOT PROVIDED IN THE REPORTED EVENT OR AVAILABLE AT THE TIME OF REPORT SUBMISSION. THE COMPANY IS SEEKING THIS INFORMATION THROUGH THE EVENT INVESTIGATION. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). 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.
AS REPORTED VIA THE EXCELLENT STUDY (B)(6), A 76-YEAR-OLD MALE (SUBJECT (B)(6)) WITH A MEDICAL HISTORY OF ATRIAL FIBRILLATION AND CONGESTIVE HEART FAILURE, PRESENTED WITH AN UNWITNESSED WAKE-UP STROKE. LAST TIME SEEN WELL WAS ON (B)(6) 2024 AT 21:00. SYMPTOMS WERE FIRST OBSERVED ON (B)(6) 2024 AT 04:11. THE PATIENT WAS THEN PRESENTED TO THE TREATING HOSPITAL ON (B)(6) 2024 AT 05:28, WHERE CT IMAGING CONFIRMED AN ISCHEMIC STROKE. INTRAVENOUS TISSUE PLASMINOGEN ACTIVATOR (TPA) WAS NOT ADMINISTERED AT THE TIME OF STROKE PRESENTATION. THE SUSPECTED ORIGIN OF THE EMBOLISM WAS ¿UNDETERMINED ETIOLOGIES.¿ THE PATIENT¿S BASELINE NIHSS SCORE WAS 7 AND MODIFIED RANKIN SCALE (MRS) SCORE WAS ¿0-NO SYMPTOMS.¿ ON (B)(6) 2024, THE PATIENT UNDERWENT AN ENDOVASCULAR MECHANICAL THROMBECTOMY USING AN UNKNOWN EMBOVAC DEVICE (PRODUCT CODE/ LOT # UNKNOWN) FOR AN OCCLUSION AT THE M1 SEGMENT OF THE RIGHT MIDDLE CEREBRAL ARTERY (MCA). THE PRE-PASS MTICI SCORE WAS 0. THE 1ST PASS RESULTED IN A MTICI SCORE OF 3, WITH CLOT RETRIEVAL. DURING THE PROCEDURE, A GUIDEWIRE WAS USED, BUT THE BRAND WAS NOT SPECIFIED. AN 8 BOBBY BALLOON GUIDE WAS ALSO USED. THERE WERE NO STUDY DEVICE DEFICIENCIES DURING THE PROCEDURE. THE PATIENT¿S 24-HOUR POST-PROCEDURE NIHSS SCORE WAS 0. ON (B)(6) 2024, THE PATIENT EXPERIENCED THE EVENT OF ¿RIGHT MCA PETECHIAL HEMORRHAGE,¿ WHICH BECAME KNOWN TO THE SITE AND SPONSOR 17-JUL-2024. THE PRINCIPAL INVESTIGATOR (PI) ASSESSED THIS EVENT AS NOT SERIOUS, MILD IN SEVERITY, AND AS UNRELATED TO THE EMBOTRAP III STUDY DEVICE, POSSIBLY RELATED TO THE LARGE BORE CATHETER, UNRELATED TO THE CEREGLIDE71, AND POSSIBLY RELATED TO THE PRIMARY SURGICAL PROCEDURE. THE EVENT WAS NOT MEDICALLY/SURGICALLY TREATED. THE OUTCOME IS RECORDED AS ¿RECOVERING/RESOLVING,¿ WITH NO END DATE LISTED. ADDITIONAL/MODIFIED INFORMATION WAS RECEIVED ON 24-JUL-2024. SUMMARY: REGARDING THE ADVERSE EVENT OF ¿RIGHT MCA PETECHIAL HEMORRHAGE,¿ THE OUTCOME WAS UPDATED FROM "RECOVERING/RESOLVING" TO "NOT RECOVERED/NOT RESOLVED." ADDITIONAL INFORMATION WAS ALSO NOTED ON THE CLINICAL DATABASE AT THE TIME OF THIS REVIEW, 24-JUL-2024. SUMMARY: ON (B)(6) 2024, THE PATIENT WAS DISCHARGED HOME FOR SELF-CARE WITH AN NIHSS SCORE OF 1 AND A MRS SCORE OF ¿1-NO SIGNIFICANT DISABILITY. ABLE TO CARRY OUT ALL USUAL DUTIES AND ACTIVITIES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2075068 | 132CM LARGE BORE 71 CATHETER | CATHETER, ASPIRATION CATHETER | NRY | MEDOS INTERNATIONAL SARL | 31327431 | 10886704082378 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Male | Life Threatening | BOBBY¿ 8F BALLOON GUIDE CATHETER (TERUMO)| GUIDEWIRE (UNSPECIFIED BRAND) |