XACT CAROTID STENT SYSTEM

Report

Report Number: 2024168-2011-01265
Event Type: Injury
Date Received: March 1, 2011
Date of Event: January 24, 2011
Report Date: February 4, 2011
Manufacturer: AV-TEMECULA-CT
Product Code: NIM
PMA / PMN Number: P040038
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NV, US
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

(B)(4). 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 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. IN THIS CASE, IT APPEARS THE DIFFICULTIES CROSSING ARE RELATED TO THE ANATOMICAL CONDITIONS WHICH WERE REPORTED AS TORTUOUS. THE REPORTED PATIENT EFFECT OF NEUROLOGICAL DEFICIT/DYSFUNCTION IS A KNOWN ADVERSE EVENT AS LISTED IN THE PRODUCT INSTRUCTION FOR USE (IFU) AS A KNOWN POTENTIAL ADVERSE EFFECT. 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, DESIGN OR LABELING. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS FOR THIS LOT AND THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT DEFICIENCY.

Additional Manufacturer Narrative · 1

(B)(4). 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 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. IN THIS CASE, IT APPEARS THE DIFFICULTIES CROSSING ARE RELATED TO THE ANATOMICAL CONDITIONS WHICH WERE REPORTED AS TORTUOUS. THE REPORTED PATIENT EFFECT OF NEUROLOGICAL DEFICIT/DYSFUNCTION IS A KNOWN ADVERSE EVENT AS LISTED IN THE PRODUCT INSTRUCTION FOR USE (IFU) AS A KNOWN POTENTIAL ADVERSE EFFECT. 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, DESIGN OR LABELING. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS FOR THIS LOT AND THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT DEFICIENCY.

Additional Manufacturer Narrative · 1

(B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD IS FORTHCOMING. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE LEFT CAROTID ARTERY HAD A TYPE 3 ARCH AND A TORTUOUS COMMON CAROTID ARTERY. THE XACT STENT DELIVERY SYSTEM (SDS) WOULD NOT CROSS. THE XACT SDS WAS REMOVED FROM THE PATIENT. AFTER THE CASE, THE PATIENT WAS SYMPTOMATIC ON THE LEFT SIDE WITH LEFT ARM PARALYSIS AND UNDERWENT THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	XACT CAROTID STENT SYSTEM	CAROTID STENT SYSTEM	NIM	AV-TEMECULA-CT		0050361

Patients

Seq	Age	Sex	Outcome	Treatment
1	86 YR		Disability