PRECISE PRO RX CAROTID STENT SYSTEM
Report
- Report Number
- 9616099-2010-00635
- Event Type
- Death
- Date Received
- August 23, 2010
- Date of Event
- July 31, 2010
- Report Date
- August 6, 2010
- Manufacturer
- CORDIS DE MEXICO
- Product Code
- NIM
- PMA / PMN Number
- P030047
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RI, US
- Reporter Occupation
- OTHER
Narratives
INFORMATION WAS RECEIVED VIA THE (B)(4) STUDY THAT TWENTY-TWO DAYS POST PRECISE STENT IMPLANTATION FOR TREATMENT OF A LEFT INTERNAL CAROTID ARTERY STENOSIS THE PATIENT HAD APHASIA, DYSARTHRIA, REFLEX CHANGE, VISUAL LOSS ON THE RIGHT SIDE, HEMIPARESIS ON THE LEFT SIDE, HEMIATAXIA ON BOTH SIDES AND PRESENCE OF BABINSKI ON THE RIGHT. THE PATIENT WAS DIAGNOSED WITH AN ACUTE ISCHEMIC STROKE INVOLVING THE LEFT MIDDLE CEREBRAL ARTERY TERRITORY. ADDITIONALLY, IT WAS NOTED THAT THERE WAS NARROWING OF THE MID ASPECT OF THE STENT AND A QUESTIONABLE DISSECTION FLAP JUST DISTAL TO THE COMMON CAROTID ARTERY STENT. AN ATTEMPT AT REVASCULARIZATION WITH INTRA-ARTERIAL TPA AND MERCI RETRIEVAL WAS MADE WITH NO SIGNIFICANT CHANGE. THE PATIENT'S NEUROLOGICAL STATUS SIGNIFICANTLY DETERIORATED AFTER THIS AND HER STATUS WAS CHANGED TO COMFORT MEASURES ONLY WITH PLANS FOR DISCHARGE TO HOSPICE. THE PATIENT DIED FIVE DAYS LATER. AT INDEX PROCEDURE THE (B)(6) FEMALE PRESENTED FROM ACUTE REHABILITATION WITH APHASIA AND FACIAL DROOP. THE PATIENT HAD SUFFERED A STROKE TWO DAYS PRIOR TO THE INDEX PROCEDURE. MRA DEMONSTRATED COMPLETE OCCLUSION OF THE RIGHT INTERNAL CAROTID ARTERY (ICA) AND 75% STENOSIS OF THE LEFT ICA. ADDITIONAL MEDICAL HISTORY INCLUDED HYPERTENSION, HYPERLIPIDEMIA, CAD, ATRIAL FIBRILLATION, TIA, CHF, STATUS POST COLOSTOMY, BOWEL OBSTRUCTION AND ERCP WITH SPHINCTERECTOMY. THE (B)(6) SCORE WAS 4 WITH A (B)(6) SCORE OF 2. AT INDEX PROCEDURE A 60% STENOSIS OF THE PROXIMAL EXTERNAL CAROTID ARTERY WAS INDICATED. THE LESION WAS 20MM IN LENGTH ULCERATED AND ECCENTRIC WITH MILD TORTUOSITY WITH A REFERENCE DIAMETER OF 5.7MM. A 7MM ANGIOGUARD EMBOLIC PROTECTION DEVICE WAS DEPLOYED WITH MALFUNCTION OR ADVERSE EVENT. THERE WAS NO DOCUMENTED PRE-DILATION AND AN 8X30 PRECISE STENT WAS IMPLANTED AT THE TARGET SITE WITHOUT MALFUNCTION OR ASSOCIATED MAJOR ADVERSE EVENT. THE ANGIOGUARD WAS REMOVED WITHOUT MALFUNCTION OR ADVERSE EVENT WITH NO NEW NEUROLOGICAL EVENT UPON LEAVING THE ANGIO SUITE. THE PATIENT WAS DISCHARGED TO AN ACUTE REHAB. THERE WAS NO PRESENCE OF A DISSECTION INDICATED AND WITH FOLLOW-UP INVESTIGATION, IT WAS REPORTED THAT THERE WAS NO INDICATION OF DISSECTION DURING THE INDEX PROCEDURE AND NO OTHER NEUROLOGICAL EVENTS UP UNTIL THE EVENT TWENTY-TWO DAYS POST PROCEDURE. THE PRODUCT WAS NOT RETURNED FOR EVALUATION AND TESTING. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. ISCHEMIC STROKE IS A WELL-KNOWN DOCUMENTED POTENTIAL COMPLICATION OF THIS TYPE OF PROCEDURE AND IS LISTED IN THE INSTRUCTIONS FOR USE I(FU) AS SUCH. THIS PATIENT'S EXTENSIVE MEDICAL HISTORY INCLUDING TOTAL CONTRALATERAL OCCLUSION PUT HER AT AN INCREASED RISK FOR MAJOR ADVERSE EVENT. IN ADDITION, ALTHOUGH IT WAS REPORTED THAT THERE WAS NO DISSECTION INDICATED AT INDEX PROCEDURE, THE CT SCAN REPORTED A QUESTIONABLE DISSECTION AND NARROWING. DISSECTION IS A WELL-KNOWN AND EXTENSIVELY DOCUMENTED POTENTIAL COMPLICATION OF THIS TYPE OF PROCEDURE AND IS ALSO LISTED IN THE IFU. THERE IS NO EVIDENCE TO SUGGEST THERE WERE ANY MANUFACTURING ISSUES THAT CONTRIBUTED TO THE REPORTED EVENT. THE PHYSICAL MANIPULATION INHERENT IN THE STENT IMPLANTATION PROCEDURE INTENTIONALLY DISRUPTS THE VESSEL PLAQUE AND INTIMA IN AN EFFORT TO RECONSTRUCT VIABLE PATENT VASCULATURE AND TREAT THE ATHEROSCLEROTIC DISEASE PROCESS. IT IS POSSIBLE THAT THESE FACTORS MAY HAVE CONTRIBUTED TO THE ISCHEMIC STROKE AND THE REPORTED NARROWING IN THE STENT. HOWEVER, BASED ON THE AVAILABLE INFORMATION, NO CONCLUSION CAN BE MADE. FACTORS THAT MAY HAVE INFLUENCED THE EVENT INCLUDE PATIENT MEDICAL HISTORY, PROCEDURAL, PHARMACOLOGICAL AND LESION CHARACTERISTICS. THERE IS NO INDICATION OF ANY MANUFACTURING ISSUES RELATED TO THE EVENT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.
FOLLOWING THE PROCEDURE A CT PERFUSION SCAN WAS PERFORMED AND REVEALED THAT THERE WAS AN OCCLUSION OF THE DISTAL INTERNAL CAROTID ARTERY (ICA), M1 BRANCH OF THE MIDDLE CEREBRAL ARTERY (MCA) AND THE A1 BRANCH OF THE LEFT ANTERIOR COMMUNICATING ARTERY (ACA). THERE WAS DECREASED DENSITY WITHIN THE PROXIMAL LEFT COMMON CAROTID ARTERY ORIGIN WHICH WAS LIKELY RELATED TO MIXING; HOWEVER, A FILLING DEFECT COULD NOT BE COMPLETELY EXCLUDED. THE RIGHT COMMON ARTERY WAS OCCLUDED. THERE WAS NARROWING IN THE MID ASPECT OF THE STENT IN THE COMMON CAROTID. THERE WAS ALSO A QUESTIONABLE DISSECTION FLAP JUST DISTAL THE COMMON CAROTID STENT. HER POSTERIOR CIRCULATION WAS OTHERWISE NORMAL. THE PATIENT WAS DISCHARGED TO HOSPICE WHERE SHE LATER EXPIRED. THE CAUSE OF DEATH IS UNKNOWN. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.
APPROXIMATELY TWENTY-TWO DAYS POST INDEX PROCEDURE, THE PATIENT EXPERIENCED APHASIA, DYSARTHRIA, AND REFLEX CHANGE VISUAL LOSS ON THE RIGHT SIDE, HEMIPARESIS ON THE LEFT SIDE, HEMIATAXIA ON BOTH SIDES AND PRESENCE OF BABINSKI ON THE RIGHT. THE PATIENT WAS DIAGNOSED WITH AN ISCHEMIC STROKE. DURATION OF DEFICIT IS PERMANENT ONSET WAS SUDDEN, PATIENT DECEASED. AN (B)(6) FEMALE WITH A HISTORY OF HYPERTENSION, HYPERLIPIDEMIA, CAD, ATRIAL FIBRILLATION, TIA, CHF, STATUS POST COLOSTOMY, BOWEL OBSTRUCTION AND ERCP WITH SPHINCTEROTOMY, PRESENTS FROM ACUTE REHABILITATION WITH APHASIA AND FACIAL DROOP. THE PATIENT HAD SUFFERED A STROKE TWO PRIOR TO THE INDEX PROCEDURE. THE PATIENT WAS ENROLLED IN THE SAPPHIRE STUDY FOR STENTING OF THE PROXIMAL LEFT INTERNAL CAROTID ARTERY (ICA). THE PROCEDURE WAS SUCCESSFUL AND THERE WAS NO REPORTED INJURY TO THE PATIENT. APPROXIMATELY TWENTY-TWO DAYS AFTER THE STENTING PROCEDURE, THE PATIENT SUFFERED A NEUROLOGICAL EVENT. THE REHAB NURSE NOTED THAT THE PATIENT WAS NORMAL THE MORNING OF THE EVENT. THE PATIENT HAD BREAKFAST AS USUAL AND DURING THE 9:30 A.M. WALK THROUGH PATIENT WAS FOUND TO BE SITTING IN HER CHAIR LOOKING NORMAL. SOMETIME BETWEEN 9:00 AND 10:00 A.M., SHE FELL OFF THE CHAIR AND AT 10:00AM, THE PATIENT WAS FOUND DOWN ON THE FLOOR. PER THE NURSE AT THE ACUTE REHAB, THE PATIENT WAS LYING ON THE RIGHT SIDE. SHE WAS MOVING HER RIGHT ARM, BUT NOT TO COMMAND. SHE WOULD NOT MOVE THE LEFT ARM, AND PATIENT ALSO HAD A LEFT FACIAL DROOP AND SHE WAS NOT ABLE TO TALK. THE PATIENT WAS IMMEDIATELY TAKEN TO THE ER. A STROKE EVALUATION WAS DONE, PATIENT HAD AN (B)(6) STROKE SCALE OF 11 AND THE PATIENT WAS NOT ABLE TO FOLLOW COMMANDS. AN INTERVENTIONAL PHYSICIAN WAS CONTACTED AND AFTER REVIEWING THE FILMS, AGREED TO GO AHEAD WITH INTRA-ARTERIAL THROMBOLYTICS (IA TPA) INFUSION. THE PATIENT WENT TO INTERVENTIONAL RADIOLOGY (IR) AND WAS TREATED WITH IA TPA AND ALSO WITH MERCI RETRIEVAL.
SAME CASE AS MFR REPORT #: 2134265-2010-03858. IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE, TWO SHAFT FRACTURES OCCURRED. VASCULAR ACCESS WAS OBTAINED THROUGH THE GROIN VIA THE CONTRALATERAL APPROACH. THE LESION WAS LOCATED IN THE CALCIFIED AND TORTUOUS LEFT MID PERONEAL ARTERY. THE LESION WAS NOT PRE-DILATED. UPON ATTEMPTS TO ADVANCE THE 3.0MM X 1.5CM SMALL PERIPHERAL CUTTING BALLOON, RESISTANCE WAS ENCOUNTERED AND THE BALLOON CATHETER SHAFT KINKED AND CONSEQUENTLY FRACTURED AT THE DISTAL PORTION RIGHT BEFORE THE CUTTING BALLOON. THE PHYSICIAN ATTEMPTED TO USE ANOTHER OF THE SAME DEVICE BUT ONCE AGAIN RESISTANCE WAS ENCOUNTERED AND THE BALLOON CATHETER SHAFT KINKED AND CONSEQUENTLY FRACTURED AT THE DISTAL PORTION RIGHT BEFORE THE CUTTING BALLOON. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A STERLING BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS SATISFACTORY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRECISE PRO RX CAROTID STENT SYSTEM | SELF EXPANDING STENTS (NIM) | NIM | CORDIS DE MEXICO | NA | 15052039 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Death| H| L| R | ANGIOGUARD DISTAL PROTECTION DEVICE |