UNKNOWN

Report

Report Number: 3002808486-2015-00102
Event Type: Injury
Date Received: September 1, 2015
Date of Event: September 22, 2010
Report Date: August 3, 2017
Manufacturer: WILLIAM COOK EUROPE
Product Code: DTK
PMA / PMN Number: K090140
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: ATTORNEY

Narratives

Additional Manufacturer Narrative · 1

MANUFACTURER REFERENCE: (B)(4). CATALOG#: UNKNOWN BUT REFERRED TO AS A COOK GUNTHER TULIP FILTER. SINCE CATALOG# IS UNKNOWN THE 510(K) COULD BE EITHER K000855, K032426 OR K090140. INVESTIGATION IS STILL IN PROGRESS. MANUFACTURER REFERENCE: (B)(4). CATALOG#: UNKNOWN BUT REFERRED TO AS A COOK GUNTHER TULIP FILTER. SINCE CATALOG# IS UNKNOWN THE 510(K) COULD BE EITHER K000855, K032426 OR K090140. INVESTIGATION IS STILL IN PROGRESS.

Additional Manufacturer Narrative · 1

(B)(4). CATALOG#: UNKNOWN BUT REFERRED TO AS A COOK GUNTHER TULIP FILTER. INVESTIGATION IS STILL IN PROGRESS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

Additional Manufacturer Narrative · 1

(B)(4)/ CATALOG#: UNKNOWN BUT REFERRED TO AS A COOK GUNTHER TULIP FILTER. SUMMARY OF INVESTIGATIONAL FINDINGS: SINCE NO DEVICE OR IMAGING STUDIES HAVE BEEN AVAILABLE AND ONLY LIMITED MEDICAL RECORDS HAVE BEEN MADE AVAILABLE THE EXACT ROOT CAUSE FOR WHAT CAUSED THE ALLEGED PERFORATION OF SEVERAL TINES IS UNKNOWN. FILTER PERFORATION OF THE VENA CAVA WALL IS A KNOWN RISK REPORTED IN THE PUBLISHED SCIENTIFIC LITERATURE. ALSO, IT IS DESCRIBED THAT MANIPULATION IN THE AREA OF FILTER PLACEMENT COULD CONTRIBUTE TO CHANGES TO THE FILTER CONFIGURATION AND PLACEMENT THEREBY POTENTIALLY INITIATE PERFORATION OF THE VENA CAVA WALL. NO EVIDENCE TO SUGGEST THAT THIS DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS AND NOTHING INDICATES THAT THE FILTER DID NOT PERFORM AS INTENDED, E.G. INTENDED FOR THE PREVENTION OF RECURRENT PULMONARY EMBOLISM (PE) VIA PLACEMENT IN THE VENA CAVA. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

Additional Manufacturer Narrative · 1

(B)(4). NAME AND ADDRESS FOR IMPORTER SITE: (B)(4). CORRECTED DATA BASED ON NEW INFORMATION RECEIVED: INITIAL REPORTER: (B)(6). THE EVENT IS CURRENTLY UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE PROVIDED UPON CONCLUSION.

Additional Manufacturer Narrative · 1

(B)(4). IT HAS NOT BEEN POSSIBLE TO FURTHER INVESTIGATE OR EVALUATE THIS ALLEGED EVENT BASED ON THE LIMITED INFORMATION PROVIDED TO DATE VIA THE OPERATIVE NOTE STATING 'MIGRATION, TILT, VENA CAVA PERFORATION, BLEEDING, ORGAN PERFORATION, PAIN'. COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVED WARRANTING SUPPLEMENTATION IN ACCORDANCE WITH 21 C.F.R. 803.56. MANIPULATION IN THE AREA OF THE FILTER IMPLANT MAY CAUSE MIGRATION OR CONTRIBUTE TO CHANGES IN THE FILTER CONFIGURATION AND PLACEMENT. VENA CAVA WALL PERFORATION IS A KNOWN POTENTIAL COMPLICATION OF VENA CAVA FILTERS. BOTH SYMPTOMATIC AND ASYMPTOMATIC EVENTS HAVE BEEN REPORTED. AMONG OTHER CAUSES, VENA CAVA WALL PERFORATION MAY INADVERTENTLY BE INITIATED BY IMPROPER DEPLOYMENT, EXCESSIVE FORCE OR MANIPULATIONS NEAR AN IMPLANTED FILTER (E.G., A SURGICAL PROCEDURE IN THE VICINITY OF A FILTER) AND (OR) PROCEDURES THAT INVOLVE OTHER DEVICES BEING PASSED THROUGH AN IN SITU FILTER. THERE IS A CURRENT DEBATE IN THE PUBLISHED SCIENTIFIC LITERATURE ON A DIFFERENTIATION BETWEEN IVC WALL PERFORATION WITH AND WITHOUT CLINICAL SEQUELAE. E.G. FILTER LEGS MAY BE OUTSIDE THE CONTRAST LUMEN ON IMAGING WITHOUT ACTUALLY PERFORATING THE IVC WALL (KNOWN AS TENTING) AND WITH NO CLINICAL SEQUELAE. IN CONTRAST, PERFORATION OF ADJACENT ORGANS IS REPORTED WITH CLINICAL SEQUELAE. FILTER TILT IS A KNOWN RISK IN RELATION TO FILTER IMPLANT REPORTED IN THE PUBLISHED SCIENTIFIC LITERATURE AND MAY OCCUR DURING PLACEMENT OR DURING IMPLANTING PERIOD. NO EVIDENCE TO SUGGEST THAT THIS DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS AND NOTHING INDICATES THAT THE FILTER DID NOT PERFORM AS INTENDED, E.G. INTENDED FOR THE PREVENTION OF RECURRENT PULMONARY EMBOLISM (PE) VIA PLACEMENT IN THE VENA CAVA.

Description of Event or Problem · 1

DESCRIPTION ACCORDING TO SHORT FORM COMPLAINT FILED: IT IS ALLEGED THAT "[PT] WAS IMPLANTED WITH A COOK GUNTHER TULIP FILTER ON (B)(6) 2010 AT (B)(6)". PATIENT OUTCOME: IT IS ALLEGED THAT PT WAS INJURED WITHOUT FURTHER EXPLANATION. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED BUT NOT YET PROVIDED.

Description of Event or Problem · 1

DESCRIPTION ACCORDING TO SHORT FORM COMPLAINT FILED: IT IS ALLEGED THAT "[PT] WAS IMPLANTED WITH A COOK GUNTHER TULIP FILTER ON (B)(6) 2010 AT THE (B)(6) MEDICAL CENTER, (B)(6)". ADDITIONAL INFORMATION RECEIVED (B)(6) 2016: PER THE OPERATIVE NOTE FROM (B)(6), THE PROCEDURE WAS DONE THROUGH THE RIGHT NECK. THE HOOK WAS SNARED, AND A CELECT FILTER PLACED IN (B)(6) 2009 FOR A COIL EMBOLIZATION OF LEFT ILIAC ARTERIAL BRANCH PERFORMED ON (B)(6) 2009, AND WAS LATER REMOVED INTACT AND WITHOUT INCIDENT ((B)(4)). A NEW GUNTHER TULIP IVC FILTER WAS DEPLOYED IN THE INFRARENAL IVC. THE FILTER HAD SOME MILD TILTING TO THE RIGHT ((B)(4)). PER THE PPF, ON (B)(6) 2010 AT (B)(6), THE CELECT FILTER WAS REMOVED THROUGH THE RIGHT INTERNAL JUGULAR VEIN BECAUSE OF PAIN AND PENETRATION OF THE CAVAL WALL WITH SEVERAL TINES OF THE FILTER ((B)(4)). ON (B)(6) 2010 THE GUNTHER TULIP FILTER WAS REMOVED AT TEXAS HEALTH THROUGH THE RIGHT INTERNAL JUGULAR VEIN BECAUSE OF PAIN AND PENETRATION OF THE CAVAL WALL WITH SEVERAL TINES OF THE FILTER ((B)(4)). PATIENT OUTCOME: IT IS ALLEGED THAT PT WAS INJURED WITHOUT FURTHER EXPLANATION.

Description of Event or Problem · 1

DESCRIPTION ACCORDING TO SHORT FORM COMPLAINT FILED: IT IS ALLEGED THAT "[PT] WAS IMPLANTED WITH A COOK GUNTHER TULIP FILTER ON (B)(6) 2010 AT (B)(6)". ADDITIONAL INFORMATION RECEIVED 19JAN2016: PER THE OPERATIVE NOTE FROM (B)(6), THE PROCEDURE WAS DONE THROUGH THE RIGHT NECK. THE HOOK WAS SNARED, AND A CELECT FILTER PLACED IN (B)(6) 2009 FOR A COIL EMBOLIZATION OF LEFT ILIAC ARTERIAL BRANCH PERFORMED ON (B)(6) 2009, AND WAS LATER REMOVED INTACT AND WITHOUT INCIDENT ((B)(4)). A NEW GUNTHER TULIP IVC FILTER WAS DEPLOYED IN THE INFRARENAL IVC. THE FILTER HAD SOME MILD TILTING TO THE RIGHT ((B)(4)). PER THE PPF, ON (B)(6) 2010 AT (B)(6), THE CELECT FILTER WAS REMOVED THROUGH THE RIGHT INTERNAL JUGULAR VEIN BECAUSE OF PAIN AND PENETRATION OF THE CAVAL WALL WITH SEVERAL TINES OF THE FILTER ((B)(4)). ON (B)(6) 2010 THE GUNTHER TULIP FILTER WAS REMOVED AT (B)(6) THROUGH THE RIGHT INTERNAL JUGULAR VEIN BECAUSE OF PAIN AND PENETRATION OF THE CAVAL WALL WITH SEVERAL TINES OF THE FILTER ((B)(4)). PATIENT OUTCOME: IT IS ALLEGED THAT PT WAS INJURED WITHOUT FURTHER EXPLANATION.

Description of Event or Problem · 1

THIS ADDITIONAL INFORMATION WAS RECEIVED ON 09/08/2015 AS FOLLOWS: PLAINTIFF ALLEGEDLY RECEIVED AN IMPLANT ON (B)(6) 2010 VIA THE RIGHT INTERNAL JUGULAR VEIN DUE TO A HYPERCOAGULABLE DISORDER AND A BLEEDING GASTRIC ULCER. PLAINTIFF ALLEGEDLY HAD A SUCCESSFUL RETRIEVAL ON (B)(6) 2010. PLAINTIFF IS ALLEGING MIGRATION, TILT, VENA CAVA PERFORATION, BLEEDING, ORGAN PERFORATION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
577942	UNKNOWN	DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR	DTK	WILLIAM COOK EUROPE

Patients

Seq	Age	Sex	Outcome	Treatment
1	29 YR		Life Threatening