XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
Report
- Report Number
- 2024168-2010-02789
- Event Type
- Death
- Date Received
- December 17, 2010
- Date of Event
- December 2, 2010
- Report Date
- December 7, 2010
- Manufacturer
- AV-TEMECULA-CT
- Product Code
- NIQ
- PMA / PMN Number
- P070015
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
(B)(4). DEVICE (B)(4) IMPROPER OR INCORRECT PROCEDURE OR METHOD (RE-INSERTION). PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFORMATION; HOWEVER, IT WAS NOT POSSIBLE TO PERFORM A THOROUGH ANALYSIS ON THE PRODUCT BECAUSE IT WAS NOT RETURNED TO ABBOTT VASCULAR FOR INVESTIGATION. THE INABILITY TO CROSS A LESION CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, DEVICE PLACEMENT TECHNIQUE, DEVICE SIZE SELECTION AND ACCESSORY DEVICE SUPPORT; AND IS TYPICALLY NOT ASSOCIATED WITH A PRODUCT QUALITY DEFICIENCY. ALTHOUGH THE ANATOMICAL CONDITION WAS NOT REPORTED, THE FAILURE TO ADVANCE IS NOT GENERALLY ASSOCIATED WITH A PRODUCT QUALITY DEFICIENCY AND WAS LIKELY RELATED TO CIRCUMSTANCES OF THE PROCEDURE. ADDITIONALLY, DAMAGE TO THE STENT MAY OCCUR AS A RESULT OF AN INTERACTION BETWEEN THE MOUNTED STENT AND THE ANATOMY AND/OR ACCESSORIES DURING ADVANCEMENT OF THE PRODUCT OR AS A RESULT OF AN INTERACTION BETWEEN THE MOUNTED STENT AND THE TIP OF THE GUIDING CATHETER AND/OR RHV DURING RETRACTION OF THE PRODUCT. REPORTEDLY, AFTER THE INITIAL FAILED ATTEMPT TO CROSS, BALLOON ANGIOPLASTY AND INTRAVASCULAR ULTRASOUND WAS PERFORMED. THEN, THE SAME XIENCE V STENT DELIVERY SYSTEM (SDS) WAS RE-INSERTED AND THE STENT DEPLOYED. IT SHOULD BE NOTED THAT THE XIENCE V INSTRUCTIONS FOR USE (IFU) CAUTIONS THE USER THAT AN UNEXPANDED STENT MAY BE RETRACTED INTO THE GUIDING CATHETER ONE TIME ONLY. AN UNEXPANDED STENT SHOULD NOT BE REINTRODUCED INTO THE ARTERY ONCE IT HAS BEEN PULLED BACK INTO THE GUIDING CATHETER. SUBSEQUENT MOVEMENT IN AND OUT THROUGH THE DISTAL END OF THE GUIDING CATHETER SHOULD NOT BE PERFORMED AS THE STENT MAY BE DAMAGED AND/OR DISLODGED FROM THE BALLOON WHEN RETRACTING THE UNDEPLOYED STENT BACK INTO THE GUIDING CATHETER. IT IS UNKNOWN IF RE-INSERTION OF THE SDS CONTRIBUTED TO THE REPORTED FLARED STRUT. HOWEVER, SINCE THERE WAS NO REPORT OF ANY DAMAGE OBSERVED TO THE STENT IMPLANT PRIOR TO THE PROCEDURE, THIS MAY SUGGEST THAT A PRODUCT DEFICIENCY DID NOT CONTRIBUTE TO THE REPORTED STENT DAMAGE. TO ENSURE THIS TYPE OF EVENT IS NOT THE RESULT OF A PRODUCT DEFICIENCY, ALL SDS ARE 100% VISUALLY INSPECTED ONLINE FOR STENT DAMAGE, INCLUDING AT THE POINT THAT THE PROTECTIVE SHEATH IS PLACED ON THE STENT. THE LOT HISTORY RECORD FOR THIS PRODUCT WAS NOT REVIEWED BECAUSE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS AND THE LOT NUMBER WAS NOT REPORTED. THE FAILURE TO CROSS AND STENT DAMAGE ARE MOST LIKELY RELATED TO OPERATIONAL CONTEXT, ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE OR DESIGN.
(B)(4). THE DEVICE REMAINS IN THE PATIENT. THE LOT NUMBER WAS NOT PROVIDED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.
(B)(4): AFTER ICU BRAIN-HYPOTHERMIA WAS PERFORMED WITH INTRAAORTIC BALLOON PUMP AND PCPS. CATECHOLAMINE THERAPY AND A BLOOD TRANSFUSION WAS PERFORMED; (B)(4). THE CARDIAC DEATH ON (B)(6)-2010, WAS DUE TO PUMP FAILURE. FROM THE CT SCAN, HYPOXIC ENCEPHALOPATHY WAS CONFIRMED. AN AUTOPSY WAS NOT PERFORMED. NO ADDITIONAL INFORMATION WAS PROVIDED. THE PHYSICIAN DID NOT KNOW THE REASON WHY THE STENT THROMBOSIS OCCURRED, BECAUSE THE STENT MALAPPOSITION WAS ONLY ONE STRUT THAT WAS FLARED, SO HE THOUGHT THAT IT WAS NOT THE REASON FOR THE STENT THROMBOSIS. THE PHYSICIAN THINKS THAT THE REASON FOR THE DEATH IS BECAUSE OF THE HEART FAILURE. A FLARED STRUT AFTER DEPLOYMENT CAN BE A RESULT OF, BUT ARE NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, INFLATION TECHNIQUE DURING USE OF THE PRODUCT, AN INTERACTION WITH THE PATIENT ANATOMY AND/OR PREVIOUSLY IMPLANTED STENTS, POST DILATATION TECHNIQUE. TO ENSURE THIS TYPE OF OCCURRENCE IS NOT RELATED TO A POTENTIAL MANUFACTURING OR PRODUCT DEFICIENCY, ALL STENT DELIVERY SYSTEMS ARE CONFIRMED BY VARIOUS QUALITY CHECKS TO VERIFY VISUAL, FUNCTIONAL AND DIMENSIONAL SPECIFICATIONS, INCLUDING PROPER BALLOON DIMENSIONS, AND PROPER STENT PLACEMENT. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY PROPER INFLATION AND STENT DEPLOYMENT. HEART FAILURE IS A KNOWN ADVERSE EVENT AS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE. A DEFINITIVE CAUSE OF THE REPORTED DIFFICULTIES CANNOT BE DETERMINED; HOWEVER, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY.
(B)(6): ANGINA, CARDIAC ARREST, THROMBOSIS, OCCLUSION AND DEATH ARE KNOWN ADVERSE EVENTS AS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE OR DESIGN. THE PHYSICIAN DID NOT KNOW THE REASON WHY THE STENT THROMBOSIS OCCURRED, BECAUSE THE STENT MALAPPOSITION WAS ONLY ONE STRUT THAT WAS FLARED, SO HE THOUGHT THAT IT WAS NOT THE REASON FOR THE STENT THROMBOSIS. THE PHYSICIAN THINKS THAT THE REASON FOR THE DEATH IS BECAUSE OF THE HEART FAILURE.
IT WAS REPORTED THAT THE TARGET LESION WAS IN THE LEFT MAIN TRUNK (LMT) AND THE LEFT CIRCUMFLEX (LCX) ARTERY. ON (B)(6) 2010, A ROTABLATOR WAS USED AT THE TARGET LESION SITE AND THE XIENCE V WAS IMPLANTED. A KISSING BALLOON TECHNIQUE WAS THEN PERFORMED AT THE LMT/LEFT ANTERIOR DESCENDING (LAD) AND AT THE LMT/LCX. INTRAVASCULAR ULTRA SOUND WAS PERFORMED AND THE PROCEDURE WAS COMPLETED. ON (B)(6) 2010, THE PATIENT EXPERIENCED CHEST PAIN AND WAS TAKEN TO THE HOSPITAL; THE PATIENT HAD ALREADY BEEN IN CARDIOPULMONARY ARREST. PERCUTANEOUS CARDIOPULMONARY SUPPORT WAS INSERTED AND CORONARY ANGIOGRAPHY WAS PERFORMED IMMEDIATELY. A TOTAL OCCLUSION WAS FOUND AT THE LMT, SO THE THROMBUS WAS ASPIRATED WITH AN ASPIRATION CATHETER. THE BLOOD FLOW WAS RECOVERED TO TIMI II AND THE PATIENT WAS TAKEN TO THE INTENSIVE CARE UNIT. ON (B)(6) 2010, THE PATIENT DIED. NO ADDITIONAL INFORMATION WAS PROVIDED.
THE PROCEDURE WAS ON (B)(6)-2010. IT WAS REPORTED THAT THE TARGET LESION WAS IN THE LEFT MAIN TRUNK (LMT) AND THE LEFT CIRCUMFLEX (LCX) ARTERY. THE PATIENT WAS ADMINISTERED A STEROID AND GOT A RASH WHEN ANGIOGRAPHY WAS PERFORMED, BUT THE PROCEDURE WAS CONTINUED AND IT DID NOT LEAD TO EXACERBATION OF THE RASH SO THE CORONARY INTERVENTION WAS CONTINUED. A ROTABLATOR WAS USED AT THE TARGET LESION SITE; HOWEVER, THE INTRAVASCULAR ULTRASOUND (IVUS) WAS NOT ABLE TO CROSS THE LESION. BALLOON ANGIOPLASTY AND INTRAVASCULAR ULTRASOUND WAS THEN PERFORMED. THE XIENCE V 3.0 X 18 WAS THEN IMPLANTED AT 14 ATMOSPHERES (ATM), BUT AFTER IMPLANTING THE STENT, THE SMALL RAMUS WAS OCCLUDED. A KISSING BALLOON TECHNIQUE WAS PERFORMED AT THE LMT AT 14 ATM. THE PHYSICIAN FOUND THAT MID LMT HAD STENT MALAPPOSITION; THEREFORE, A HUGGING BALLOON TECHNIQUE WAS PERFORMED AT 14 ATM AT THE MID LMT. THE STENT MALAPPOSITION WAS PRETTY MUCH RESOLVED; WITH ONLY 1 MM LENGTH. THE PROCEDURE WAS COMPLETED. THE FINAL STENOSIS OF THE LMT OSTIUM WAS 0%. ON (B)(6)-2010, THE PATIENT EXPERIENCED CHEST PAIN AND WAS TAKEN TO THE HOSPITAL; THE PATIENT HAD ALREADY BEEN IN CARDIOPULMONARY ARREST. PERCUTANEOUS CARDIOPULMONARY SUPPORT (PCPS) WAS INSERTED AND CORONARY ANGIOGRAPHY WAS PERFORMED IMMEDIATELY. A TOTAL OCCLUSION WAS FOUND AT THE LMT, SO THE THROMBUS WAS ASPIRATED WITH AN ASPIRATION CATHETER. THE BLOOD FLOW WAS RECOVERED TO TIMI II AND THE PATIENT WAS TAKEN TO THE INTENSIVE CARE UNIT (ICU).
THE PROCEDURE WAS ON (B)(6)-2010. IT WAS REPORTED THAT THE TARGET LESION WAS IN THE LEFT MAIN TRUNK (LMT) AND THE LEFT CIRCUMFLEX (LCX) ARTERY. THE PATIENT WAS ADMINISTERED A STEROID AND GOT A RASH WHEN ANGIOGRAPHY WAS PERFORMED, BUT THE PROCEDURE WAS CONTINUED AND IT DID NOT LEAD TO EXACERBATION OF THE RASH SO THE CORONARY INTERVENTION WAS CONTINUED. A ROTABLATOR WAS USED AT THE TARGET LESION SITE; HOWEVER, THE XIENCE V 3.0X18 WAS NOT ABLE TO CROSS THE LESION. BALLOON ANGIOPLASTY AND INTRAVASCULAR ULTRASOUND WAS PERFORMED. THE XIENCE V 3.0X18 WAS THEN IMPLANTED AT 14 ATMOSPHERES (ATM), BUT AFTER IMPLANTING THE STENT, THE SMALL RAMUS WAS OCCLUDED. A KISSING BALLOON TECHNIQUE WAS PERFORMED AT THE LMT AT 14 ATM. THE PHYSICIAN FOUND THAT MID LMT HAD STENT MALPOSITION; THEREFORE, A HUGGING BALLOON TECHNIQUE WAS PERFORMED AT 14 ATM AT THE MID LMT. THE STENT MALPOSITION WAS PRETTY MUCH RESOLVED; WITH ONLY 1 MM LENGTH. THE PROCEDURE WAS COMPLETED. THE FINAL STENOSIS OF THE LMT OSTIUM WAS 0%. ON (B)(6)-2010, THE PATIENT EXPERIENCED CHEST PAIN AND WAS TAKEN TO THE HOSPITAL; THE PATIENT HAD ALREADY BEEN IN CARDIOPULMONARY ARREST. PERCUTANEOUS CARDIOPULMONARY SUPPORT WAS INSERTED AND CORONARY ANGIOGRAPHY WAS PERFORMED IMMEDIATELY. A TOTAL OCCLUSION WAS FOUND AT THE LMT, SO THE THROMBUS WAS ASPIRATED WITH AN ASPIRATION CATHETER. THE BLOOD FLOW WAS RECOVERED TO TIMI II AND THE PATIENT WAS TAKEN TO THE INTENSIVE CARE UNIT. ON (B)(6)-2010, THE PATIENT DIED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM | DRUG ELUTING CORONARY STENT SYSTEM | NIQ | AV-TEMECULA-CT |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Death |