ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE SYSTEM
Report
- Report Number
- 1016427-2010-00123
- Event Type
- Injury
- Date Received
- October 15, 2010
- Date of Event
- March 11, 2009
- Report Date
- May 18, 2009
- Manufacturer
- CORDIS CORPORATION
- Product Code
- NTE
- PMA / PMN Number
- K062531
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT HAD AN ADDITIONAL PROCEDURE APPROXIMATELY SIX WEEKS AFTER THE INDEX PROCEDURE TO TREAT ANOTHER LESION IN THE LEFT INTERNAL CAROTID ARTERY (LICA) WITH AN ADDITIONAL PRECISE 9 X 40 STENT. A 5 MM ANGIOGUARD EMBOLIC PROTECTION DEVICE WAS ALSO USED FOR THE PROCEDURE. DURING THE PROCEDURE, THE PATIENT DEVELOPED PARALYSIS ON THE RIGHT SIDE OF THE BODY. CEREBRAL INFARCTION WAS CONFIRMED ON THE IPSILATERAL SIDE BY MRI. DETAIL OF TREATMENT WAS NOT PROVIDED, HOWEVER IT WAS REPORTED THAT THE PATIENT RECOVERED. NO ADDITIONAL INFORMATION IS AVAILABLE. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. THIS IS ONE OF THREE PRODUCTS USED FOR THE SAME PATIENT. PLEASE REFERENCE MFR. REPORT #9616099-2009-00946; 1016427-2010-00123; AND 9616099-2010-00797.
AT INDEX PROCEDURE, THIS POST MARKET STUDY PATIENT UNDERWENT RIGHT CAROTID ARTERY STENT IMPLANTATION AND DURING THE PROCEDURE SUFFERED AN EPISODE OF HYPOTENSION. IT WAS ALSO REPORTED THAT PLAQUE WAS PROTRUDING THROUGH THE CELLS OF THE STENT AFTER IMPLANTATION. THIS IS A (B)(6) MALE WITH MEDICAL HISTORY INCLUDING HYPERTENSION, DIABETES, HYPERLIPIDEMIA, PREVIOUS MI, PREVIOUS PCI, AND CONTRALATERAL STROKE. THE TARGET LESION WAS RIGHT INTERNAL CAROTID ARTERY DESCRIBED AS MILDLY CALCIFIED, NON-TORTUOUS BUT THE RATE OF STENOSIS WAS UNKNOWN. AN ANGIOGUARD DEVICE WAS NOT USED FOR THIS PROCEDURE. THE TARGET LESION WAS PRE-DILATED WITH AN UNKNOWN BALLOON. ONE PRECISE STENT WAS IMPLANTED WITHOUT REPORT OF DIFFICULTIES. THE TARGET LESION WAS POST-DILATED WITH AN UNKNOWN BALLOON. DURING THE PROCEDURE, THE PATIENT'S BLOOD PRESSURE DROPPED AND DOPAMINE WAS GIVEN IV FOR PRESSURE SUPPORT. THE BLOOD PRESSURE RETURNED TO NORMAL LEVELS TWO DAYS POST PROCEDURE. ACCORDING TO THE PHYSICIAN, RADIAL FORCE WAS APPLIED TO THE CAROTID ARTERY BY THE STENT PLACEMENT AND WHICH CAUSED CAROTID SINUS REFLEX. ALSO OBSERVED DURING THE PROCEDURE, PLAQUES WERE PROTRUDING THROUGH THE OPEN CELL DESIGN OF THE STENT. ARGATROBAN IV WAS GIVEN. THE PATIENT EXPERIENCED NO NEUROLOGIC SYMPTOMS DURING OR AFTER THE PROCEDURE. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT HAD AN ADDITIONAL PROCEDURE APPROXIMATELY SIX WEEKS AFTER THE INDEX PROCEDURE TO TREAT ANOTHER LESION IN THE LEFT INTERNAL CAROTID ARTERY (LICA) WITH IMPLANTATION OF A 9X40 PRECISE STENT. A 5 MM ANGIOGUARD EMBOLIC PROTECTION DEVICE WAS ALSO USED FOR THE PROCEDURE. DURING THE PROCEDURE, THE PATIENT DEVELOPED PARALYSIS ON THE RIGHT SIDE OF THE BODY. CEREBRAL INFARCTION WAS CONFIRMED ON THE IPSILATERAL SIDE BY MRI. DETAIL OF TREATMENT WAS NOT PROVIDED, HOWEVER IT WAS REPORTED THAT THE PATIENT RECOVERED. THERE IS NO ADDITIONAL PROCEDURAL OR TARGET LESION INFORMATION AVAILABLE. (B)(4): THE PRODUCT WAS NOT RETURNED FOR INSPECTION. NOTE: LAKE REGION LOT NUMBER C1998585 IS CORDIS LOT NUMBER 70408999. PER LAKE REGION REPORT (B)(4): LAKE REGION MEDICAL IS UNABLE TO DETERMINE THE EXACT CAUSE FOR THIS INCIDENT. LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT C1998585. THIS PACKAGING LOT CONTAINED 53 UNITS, WHICH WERE SHIPPED FROM LAKE REGION MEDICAL ON MAY 1, 2008. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. STROKE IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE CAROTID STENT IMPLANTATION PROCEDURE AS LISTED IN THE INSTRUCTIONS FOR USE. DURING INTERVENTIONAL PROCEDURES, THE DEVICES ARE ADVANCED AND WITHDRAWN THROUGH ACCESSORY ARTERIES TO TREAT THE TARGET LESION. THE PHYSICAL MANIPULATION OF THE ARTERIES MAY RESULT IN EMBOLIZATION OF DEBRIS FROM THE INTIMAL LAYERS OF THESE ARTERIES. BASED ON THE LIMITED PROCEDURAL INFORMATION WITHOUT INFORMATION REGARDING THE TIMING OF THE EVENT, VESSEL LESION CHARACTERISTICS AND SIZING, NO CONCLUSION CAN BE MADE REGARDING CONTRIBUTING FACTORS; HOWEVER, PROCEDURAL/CLINICAL FACTORS MAY HAVE CONTRIBUTED. THERE IS NO EVIDENCE TO SUGGEST THERE WERE ANY MANUFACTURING ISSUES THAT CONTRIBUTED TO THE REPORTED EVENT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS IS ONE OF THREE PRODUCTS USED FOR THE SAME PATIENT. PLEASE REFERENCE MFR REPORT #9616099-2009-00946; 1016427-2010-00123; AND 9616099-2010-00797.
THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT THE PATIENT WAS INCLUDED IN A (B)(6) STUDY. THE REPORT STATED THAT DURING THE PATIENT'S INDEX PROCEDURE FOR CAROTID STENT PLACEMENT THE PATIENT EXPERIENCED HYPOTENSION. THE PATIENT WAS ADMINISTERED DOPAMINE HYDROCHLORIDE FOR TWO (2) DAYS AND RECOVERED. ALSO, THE REPORT STATED THAT PLAQUE WAS OBSERVED COMING OUT OF THE STENT CELLS. ARGATROBAN HYDRATE WAS ADMINISTERED. THE PROCEDURE WAS ELECTIVE WITH THE INDICATION FOR THE PROCEDURE BEING SYMPTOMATIC STROKE. THE TARGET LESION (TL) WAS THE RIGHT INTERNAL CAROTID ARTERY. THE LESION WAS REPORTED TO BE: MILDLY CALCIFIED, AND NOT TORTUOUS. THE LESION WAS PRE-DILATED WITH A 3.5 MM UNKNOWN BALLOON CATHETER AT 6 ATM. THE PERCENT STENOSIS WAS NOT PROVIDED. AN ANGIOGUARD EMBOLIC PROTECTION DEVICE WAS NOT USED FOR THE PROCEDURE. AN ACT OF 219 WAS RECORDED. A PRECISE 9 X 40 MM STENT WAS IMPLANTED. THE STENT WAS POST-DILATED WITH AN UNKNOWN 405 MM BALLOON AT 10 ATM. THE PATIENT WAS DISCHARGED SEVEN DAYS AFTER THE PROCEDURE WITHOUT ANY NEUROLOGICAL SYMPTOMS. THE PHYSICIAN'S COMMENT REGARDING THE EVENT WAS THAT A STRONG RADIAL FORCE WAS APPLIED TO THE CAROTID ARTERY BY THE STENT PLACEMENT WHICH CAUSED A CAROTID SINUS REFLEX.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE SYSTEM | EMBOLIC PROTECTION DEVICE (NTE) | NTE | CORDIS CORPORATION | 70408999 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Hospitalization| L | PRECISE 9 X 40 STENT |