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

Model Number	40S06
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Codes	Thrombosis (2100); Stenosis (2263)
Date of Event	09/19/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the lot number for the device was not provided, a manufacturing review could not 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.The information provided by bard 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 bard.
Event or Problem Description
It was reported through the results of a clinical trial, that approximately one year and three months post placement of a right upper arm vascular graft, the patient experienced thrombosis of vascular access and was hospitalized.Reportedly, angioplasty, thrombectomy and stent placement was performed; the patient discharged on hospital day six.
Event or Problem Description
It was reported through the results of a clinical trial, that approximately one year and three months post placement of a right upper arm vascular graft, the patient experienced thrombosis of vascular access and was hospitalized.Reportedly, angioplasty, thrombectomy and stent placement was performed; the patient discharged on hospital day six.New information: it was reported through the results of a clinical trial, that approximately one year and five months post vascular graft placement , the patient experienced thrombosis of vascular access and was hospitalized.Reportedly, angioplasty was performed and the event was considered resolved.New information: it was reported through the results of a clinical trial that approximately six months post vascular graft placement the patient experienced stenosis of vascular access.
Additional Manufacturer Narrative
Manufacturing review: as the lot number for the device was not provided, a manufacturing review could not be performed.Investigation summary: the device was not returned for evaluation.Images and medical records were not provided for review.Therefore, the investigation is inconclusive 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 and three months post placement of a right upper arm vascular graft, the patient experienced thrombosis of vascular access and was hospitalized.Reportedly, angioplasty, thrombectomy and stent placement was performed; the patient discharged on hospital day six.It was reported through the results of a clinical trial, that approximately one year and five months post vascular graft placement, the patient experienced thrombosis of vascular access and was hospitalized.Reportedly, angioplasty was performed and the event was considered resolved.
Additional Manufacturer Narrative
As the lot number for the device was not provided, a manufacturing review could not be performed.The device was not returned for evaluation.Images and medical records were not provided for review.Therefore, the investigation is inconclusive 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.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.
Additional Manufacturer Narrative
Manufacturing review: as the lot number for the device was not provided, a manufacturing review could not be performed.Investigation summary: the device was not returned for evaluation.Images and medical records were not provided for review.Therefore, the investigation is inconclusive 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 and three months post placement of a right upper arm vascular graft, the patient experienced thrombosis of vascular access and was hospitalized.Reportedly, angioplasty, thrombectomy and stent placement was performed; the patient discharged on hospital day six.New information: it was reported through the results of a clinical trial, that approximately one year and five months post vascular graft placement, the patient experienced thrombosis of vascular access and was hospitalized.Reportedly, angioplasty was performed and the event was considered resolved.New information: it was reported through the results of a clinical trial that approximately six months post vascular graft placement the patient experienced stenosis of vascular access.New information: it was reported through the results of a clinical trial that approximately one year and nine months post vascular graft placement the patient experienced thrombosis of vascular access and was hospitalized.Reportedly, angiogram, thrombectomy, and angioplasty were performed.The patient was discharged three days post admission and the event was considered resolved.

• Brand Name: IMPRA EPTFE VASCULAR GRAFT
• Common Device Name: EPTFE VASCULAR GRAFT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 7723579
• Report Number: 2020394-2018-01290
• Device Sequence Number: 1618871
• Product Code: DSY
• UDI-Device Identifier: 00801741021831
• UDI-Public: (01)00801741021831
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K004011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,s
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/12/2019

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
• Initial Date Received by Manufacturer: 06/29/2018
• Supplement Date Received by Manufacturer: 09/10/2018; 01/30/2019; 06/14/2019
• Initial Report FDA Received Date: 07/26/2018
• Supplement Report FDA Received Date: 10/05/2018; 02/14/2019; 07/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALFACALCIDOL, RANITIDINE, LATANOPROST, CODEINE; ALFACALCIDOL, RANITIDINE, LATANOPROST, CODEINE; ALFACALCIDOL, RANITIDINE, LATANOPROST, CODEINE; ALFACALCIDOL, RANITIDINE, LATANOPROST, CODEINE; BUPRENORPHINE, DARBEPOETIN ALFA, CALCIUM; BUPRENORPHINE, DARBEPOETIN ALFA, CALCIUM; BUPRENORPHINE, DARBEPOETIN ALFA, CALCIUM; BUPRENORPHINE, DARBEPOETIN ALFA, CALCIUM; DOXAZOSIN, FUROSEMIDE, INSULIN, MOXONIDINE; DOXAZOSIN, FUROSEMIDE, INSULIN, MOXONIDINE; DOXAZOSIN, FUROSEMIDE, INSULIN, MOXONIDINE; DOXAZOSIN, FUROSEMIDE, INSULIN, MOXONIDINE; PARACETAMOL, SIMVASTATIN, AMLODIPINE, CLOPIDOGREL; PARACETAMOL, SIMVASTATIN, AMLODIPINE, CLOPIDOGREL; PARACETAMOL, SIMVASTATIN, AMLODIPINE, CLOPIDOGREL; PARACETAMOL, SIMVASTATIN, AMLODIPINE, CLOPIDOGREL; ALFACALCIDOL, RANITIDINE, LATANOPROST, CODEINE; BUPRENORPHINE, DARBEPOETIN ALFA, CALCIUM; DOXAZOSIN, FUROSEMIDE, INSULIN, MOXONIDINE; PARACETAMOL, SIMVASTATIN, AMLODIPINE, CLOPIDOGREL
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Weight: 76