MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. IMPRA VASCULAR GRAFT; EPTFE VASCULAR GRAFT

Model Number	40S06
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Codes	Thrombosis (2100); Stenosis (2263); Thrombosis/Thrombus (4440)
Date of Event	08/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the lot number for the device was not provided, a manufacturing review cannot be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.
Event or Problem Description
It was reported through the results of a clinical trial that approximately one year five months post vascular graft placement in the upper arm, the subject experienced thrombosis of vascular access and was admitted to the hospital.Thrombectomy was performed and follow-up imaging demonstrated high-grade stenosis with residual thrombus at the venous anastomosis.Angioplasty was performed at the venous anastomosis and venous outflow tract.Following this, an embolectomy catheter was used to remove a platelet plug within the arterial anastomosis.Repeat imaging demonstrated residual clot and repeat thrombectomy and angioplasty were performed.The following day, imaging demonstrated the study conduit thrombosed.Thrombectomy was performed and a tunneled catheter was placed for temporary access.The subject was discharged the following day in stable condition.
Event or Problem Description
It was reported through the results of a clinical trial that approximately one year five months post vascular graft placement in the upper arm, the subject experienced thrombosis of vascular access and was admitted to the hospital.Thrombectomy was performed and follow-up imaging demonstrated high-grade stenosis with residual thrombus at the venous anastomosis.Angioplasty was performed at the venous anastomosis and venous outflow tract.Following this, an embolectomy catheter was used to remove a platelet plug within the arterial anastomosis.Repeat imaging demonstrated residual clot and repeat thrombectomy and angioplasty were performed.The following day, imaging demonstrated the study conduit thrombosed.Thrombectomy was performed and a tunneled catheter was placed for temporary access.The subject was discharged the following day in stable condition.New information: it was reported through the results of a clinical trial that approximately one year five months post vascular graft placement in the upper arm, the subject experienced thrombosis and stenosis of vascular access and was admitted to the hospital.Thrombectomy was performed and follow-up imaging demonstrated high-grade stenosis with residual thrombus at the venous anastomosis.Angioplasty was performed at the venous anastomosis and venous outflow tract.Following this, an embolectomy catheter was used to remove a platelet plug within the arterial anastomosis.Repeat imaging demonstrated residual clot and repeat thrombectomy and angioplasty were performed.The following day, imaging demonstrated the study conduit thrombosed and stenosed.Thrombectomy and angioplasty were performed and a tunneled catheter was placed for temporary access.The subject was discharged the following day in stable condition.
Additional Manufacturer Narrative
Manufacturing review: a complete manufacturing review could not be conducted for the investigation as the lot number is unknown.Investigation summary: the device was not returned for evaluation.Images and medical records were not provided for review.Therefore, the investigation is inconclusive for obstruction within device as no objective evidence has been provided to confirm any alleged deficiency with the device.Based upon the available information, the definitive root cause is unknown.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, and unit label) showed that the product labeling is adequate.
Event or Problem Description
It was reported through the results of a clinical trial that approximately one year five months post vascular graft placement in the upper arm, the subject experienced thrombosis and stenosis of vascular access and was admitted to the hospital.Thrombectomy was performed and follow-up imaging demonstrated high-grade stenosis with residual thrombus at the venous anastomosis.Angioplasty was performed at the venous anastomosis and venous outflow tract.Following this, an embolectomy catheter was used to remove a platelet plug within the arterial anastomosis.Repeat imaging demonstrated residual clot and repeat thrombectomy and angioplasty were performed.The following day, imaging demonstrated the study conduit thrombosed and stenosed.Thrombectomy and angioplasty were performed and a tunneled catheter was placed for temporary access.The subject was discharged the following day in stable condition.
Additional Manufacturer Narrative
H10: manufacturing review: a complete manufacturing review could not be conducted for the investigation as the lot number is unknown.Investigation summary: the device was not returned for evaluation.Images and medical records were not provided for review.Therefore, the investigation is inconclusive for obstruction within device as no objective evidence has been provided to confirm any alleged deficiency with the device.Based upon the available information, the definitive root cause is unknown.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, and unit label) showed that the product labeling is adequate.H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

• Brand Name: IMPRA VASCULAR GRAFT
• Common Device Name: EPTFE VASCULAR GRAFT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer Contact: judith ludwig ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 7972372
• Report Number: 2020394-2018-01914
• Device Sequence Number: 13896679
• Product Code: DSY
• UDI-Device Identifier: 00801741021831
• UDI-Public: (01)00801741021831
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K004011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 40S06
• Device Catalogue Number: 40S06
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2018
• Supplement Date Received by Manufacturer: 05/14/2019; 02/01/2022
• Initial Report FDA Received Date: 10/16/2018
• Supplement Report FDA Received Date: 05/16/2019; 03/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: B COMPLEX PLUS VITAMIN C, SENNOSIDE A+B; B COMPLEX PLUS VITAMIN C, SENNOSIDE A+B; B COMPLEX PLUS VITAMIN C, SENNOSIDE A+B; CINACALCET, FERROUS SULFATE, MULTIVITAMIN; CINACALCET, FERROUS SULFATE, MULTIVITAMIN; CINACALCET, FERROUS SULFATE, MULTIVITAMIN; FLUTICASONE PROPIONATE, DOCUSATE SODIUM; FLUTICASONE PROPIONATE, DOCUSATE SODIUM; FLUTICASONE PROPIONATE, DOCUSATE SODIUM; FLUTICASONE PROPIONATE, METOPROLOL TARTRATE; FLUTICASONE PROPIONATE, METOPROLOL TARTRATE; FLUTICASONE PROPIONATE, METOPROLOL TARTRATE; MELATONIN, DARBEPOETIN ALFA, FUROSEMIDE SODIUM; MELATONIN, DARBEPOETIN ALFA, FUROSEMIDE SODIUM; MELATONIN, DARBEPOETIN ALFA, FUROSEMIDE SODIUM; NIFEDIPINE, PANTOPRAZOLE; NIFEDIPINE, PANTOPRAZOLE; NIFEDIPINE, PANTOPRAZOLE; SALBUTAMOL, ATORVASTATIN, SODIUM BICARBONATE; SALBUTAMOL, ATORVASTATIN, SODIUM BICARBONATE; SALBUTAMOL, ATORVASTATIN, SODIUM BICARBONATE; TIOTROPIUM BROMIDE, NUTRIENTS NOS, LEVOTHYTOXINE; TIOTROPIUM BROMIDE, NUTRIENTS NOS, LEVOTHYTOXINE; TIOTROPIUM BROMIDE, NUTRIENTS NOS, LEVOTHYTOXINE; TRAZODONE, CETIRIZINE, ZOLPIDEM TARTRATE; TRAZODONE, CETIRIZINE, ZOLPIDEM TARTRATE; TRAZODONE, CETIRIZINE, ZOLPIDEM TARTRATE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 43 KG