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

Model Number	40S06
Medical Device Problem Codes	Material Puncture/Hole (1504); Obstruction of Flow (2423)
Health Effect - Clinical Codes	Hematoma (1884); Unspecified Infection (1930); Thrombus (2101)
Date of Event	05/10/2018
Type of Reportable Event	Serious Injury
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 for obstruction within device and graft hole 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 ten months post placement of a left upper arm vascular graft, the patient was hospitalized and surgical reconstruction and thrombectomy of the graft was performed.It was further reported that a hematoma, a hole in the graft and a partially clotted graft was identified.Reportedly, the event was considered resolved and the patient discharged on hospital day eight.
Event or Problem Description
It was reported through the results of a clinical trial, that approximately ten months post placement of a left upper arm vascular graft, the patient was hospitalized and surgical reconstruction and thrombectomy of the graft was performed.It was further reported that a hematoma, a hole in the graft and a partially clotted graft was identified.Reportedly, the event was considered resolved and the patient discharged on hospital day eight.New information: it was reported through the results of a clinical trial that approximately one year two months post placement of a left upper arm vascular graft, the patient experienced infection of vascular access, was hospitalized and treated with antibiotics.The patient was discharged approximately seven days post admission.Reportedly, the event is considered not resolved.
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 for obstruction within device and graft hole as no objective evidence has been provided to confirm any alleged deficiency with the device.It was also alleged that the patient experienced an infection of vascular access.However, there is no evidence that the device was involved with the infection.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 ten months post placement of a left upper arm vascular graft, the patient was hospitalized and surgical reconstruction and thrombectomy of the graft was performed.It was further reported that a hematoma, a hole in the graft and a partially clotted graft was identified.Reportedly, the event was considered resolved and the patient discharged on hospital day eight.New information: it was reported through the results of a clinical trial that approximately one year two months post placement of a left upper arm vascular graft, the patient experienced infection of vascular access which required hospitalization and treatment with antibiotics.Reportedly, the event was considered resolved and the patient was discharged approximately seven days post admission.
Additional Manufacturer Narrative
H10: 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 for obstruction within device and graft hole as no objective evidence has been provided to confirm any alleged deficiency with the device.It was also alleged that the patient experienced an infection of vascular access.However, there is no evidence that the device was involved with the infection.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 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: 7712883
• Report Number: 2020394-2018-01267
• Device Sequence Number: 10992983
• Product Code: DSY
• UDI-Device Identifier: 00801741021831
• UDI-Public: (01)00801741021831
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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
• Report Date (Section B): 04/06/2020

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: 06/26/2018
• Supplement Date Received by Manufacturer: 06/14/2019; 03/26/2020
• Initial Report FDA Received Date: 07/23/2018
• Supplement Report FDA Received Date: 07/12/2019; 04/06/2020
• 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: METOPROLOL SUCCINATE, PANTOPRAZOLE, CLOPIDOGREL; METOPROLOL SUCCINATE, PANTOPRAZOLE, CLOPIDOGREL; METOPROLOL SUCCINATE, PANTOPRAZOLE, CLOPIDOGREL; POTASSIUM CHLORIDE, GLIMEPIRIDE, ALLOPURINOL; POTASSIUM CHLORIDE, GLIMEPIRIDE, ALLOPURINOL; POTASSIUM CHLORIDE, GLIMEPIRIDE, ALLOPURINOL; RAMIPRIL, FUROSEMIDE, FERROUS SULFATE; RAMIPRIL, FUROSEMIDE, FERROUS SULFATE; RAMIPRIL, FUROSEMIDE, FERROUS SULFATE; VANCOMYCIN; VANCOMYCIN
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Weight: 77