MAUDE Adverse Event Report: C.R. BARD, INC. (GFO) LUTONIX 035 DRUG COATED BALLOON PTA CATHETER

Model Number	9004
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Reocclusion (1985); Sepsis (2067)
Date of Event	05/24/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
Analysis: the device was not returned for evaluation; therefore, the investigation was conducted based on manufacturing records, information obtained from the principal investigator, and the user facility where the index procedure occurred.A lot history review revealed this is the only complaint associated with this lot.A review of the device history record (dhr) indicates the lot was manufactured to specification and sterility records revealed the device was sterile prior to being released for distribution.The patient was discharged from (b)(6) hospital, 17 (seventeen) days after the index procedure.Six (6) days later, the patient was admitted to another medical facility and was diagnosed with sepsis.The patient was treated and fully recovered from the sepsis.Although requested, the cause for the sepsis was not provided.The investigator deemed the sepsis event not related to the study device or index procedure.While being evaluated at another medical facility, the patient was reportedly diagnosed with deteriorating bilateral atherosclerosis obliterans (aso).It was reported the patient and patient¿s family members declined further medical intervention and/or treatment.On (b)(6) 2018, the patient expired.In the opinion of the healthcare professional (hcp), the patient likely expired due to aso, while being hospitalized at the other medical facility.The investigator assessed the deterioration of aso to be possibly related to the study device.Conclusion: the patient's past medical history includes hypertension, dyslipidemia, diabetes, chronic renal disease, coronary artery disease, and rutherford class v in the left leg.The becton dickinson (b)(4) reviewed this event and felt the worsening of aso was due to natural disease progression and not related to the lutonix device that was used four months prior.A localized treatment with the lutonix drug coated balloon catheter would not worsen the patient¿s aso.The other medical facility was contacted for additional information; however, additional information has not been received at the time of this report.If additional information becomes available, a supplemental report will be provided with the relevant information.
Event or Problem Description
It was reported through a post market clinical study that during the index procedure, a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter was used to treat the target lesion located in the left superficial femoral artery (sfa) on (b)(6) 2018.The patient was discharged from the user facility, (b)(6) hospital, on (b)(6) 2018.Allegedly, the patient presented with sepsis on (b)(6) 2018 at another medical facility.The patient was hospitalized at the other medical facility, where the patient reportedly fully recovered from the sepsis during hospitalization.The investigator assessed the sepsis event to be not related to the study device or index procedure.While being evaluated at the other medical facility, the patient was reportedly diagnosed with deteriorating bilateral atherosclerosis obliterans (aso).Furthermore, it was reported the patient and patient¿s family members declined further medical intervention and /or treatment.On (b)(6) 2018, the patient expired.In the opinion of the healthcare professional (hcp), the patient likely expired due to aso, while being hospitalized at the other medical facility.The investigator has assessed that the deterioration of aso was possibly related to the study device, but not related to the index procedure.The other medical facility has been contacted for additional information; however, no additional information is available.The sample was discarded by the user facility and is not available for evaluation.
Additional Manufacturer Narrative
The event description had the following sentences changed from "while being evaluated at the other medical facility, the patient was reportedly diagnosed with deteriorating bilateral atherosclerosis obliterans (aso).Furthermore, it was reported the patient and patient¿s family members declined further medical intervention and /or treatment." to "while being evaluated at the other medical facility, the patient reportedly had ulcers and necrosis in both legs.Furthermore, the patient was reportedly diagnosed with deteriorating bilateral atherosclerosis obliterans (aso).However, it was reported the patient and patient¿s family members declined further medical intervention, bypass surgery for left anterior tibial artery, and/or treatment." the other relevant history had the following added "heart failure and aortic valve stenosis" the operator of device - other had the following information added "cardiovascular internal medicine" the report source - other field had the following information added "levant japan." analysis conclusion: the conclusion had the following information added "heart failure and aortic valve stenosis" corrected data: the analysis had the following information changed from "while being evaluated at the other medical facility, the patient was reportedly diagnosed with deteriorating bilateral atherosclerosis obliterans (aso).Furthermore, it was reported the patient and patient¿s family members declined further medical intervention and /or treatment." to "while being evaluated at the other medical facility, the patient reportedly had ulcers and necrosis in both legs.Furthermore, the patient was reportedly diagnosed with deteriorating bilateral atherosclerosis obliterans (aso).However, it was reported the patient and patient¿s family members declined further medical intervention, bypass surgery for left anterior tibial artery, and/or treatment." h3 analysis: the device was not returned for evaluation; therefore, the investigation was conducted based on manufacturing records, information obtained from the principal investigator, and the user facility where the index procedure occurred.A lot history review revealed this is the only complaint associated with this lot.A review of the device history record (dhr) indicates the lot was manufactured to specification and sterility records revealed the device was sterile prior to being released for distribution.The patient was discharged from kokura memorial hospital, 17 (seventeen) days after the index procedure.Six (6) days later, the patient was admitted to another medical facility and was diagnosed with sepsis.The patient was treated and fully recovered from the sepsis.Although requested, the cause for the sepsis was not provided.The investigator deemed the sepsis event not related to the study device or index procedure.While being evaluated at the other medical facility, the patient reportedly had ulcers and necrosis in both legs.Furthermore, the patient was reportedly diagnosed with deteriorating bilateral atherosclerosis obliterans (aso).However, it was reported the patient and patient¿s family members declined further medical intervention, bypass surgery for left anterior tibial artery, and/or treatment.On (b)(6) 2018, the patient expired.In the opinion of the health care professional (hcp), the patient likely expired due to aso, while being hospitalized at the other medical facility.The investigator assessed the deterioration of aso to be possibly related to the study device.Conclusion: the patient's past medical history includes hypertension, dyslipidemia, diabetes, chronic renal disease, coronary artery disease, heart failure, aortic valve stenosis and rutherford class v in the left leg.The becton dickinson interventional segment medical director reviewed this event and felt the worsening of aso was due to natural disease progression and not related to the lutonix device that was used four months prior.A localized treatment with the lutonix drug coated balloon catheter would not worsen the patient¿s aso.The other medical facility was contacted for additional information.If additional information becomes available, a supplemental report will be provided with the relevant information.
Event or Problem Description
It was reported through a post market clinical study that during the index procedure, a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter was used to treat the target lesion located in the left superficial femoral artery (sfa) on (b)(6) 2018.The patient was discharged from the user facility, kokura memorial hospital, on (b)(6) 2018.Allegedly, the patient presented with sepsis on (b)(6) 2018 at another medical facility.The patient was hospitalized at the other medical facility, where the patient reportedly fully recovered from the sepsis during hospitalization.The investigator assessed the sepsis event to be not related to the study device or index procedure.While being evaluated at the other medical facility, the patient reportedly had ulcers and necrosis in both legs.Furthermore, the patient was reportedly diagnosed with deteriorating bilateral atherosclerosis obliterans (aso).However, it was reported the patient and patient¿s family members declined further medical intervention, bypass surgery for left anterior tibial artery, and/or treatment.On (b)(6) 2018, the patient expired.In the opinion of the health care professional (hcp), the patient likely expired due to aso, while being hospitalized at the other medical facility.The investigator has assessed that the deterioration of aso was possibly related to the study device, but not related to the index procedure.The other medical facility has been contacted for additional information; however, no additional information is available.The sample was discarded by the user facility and is not available for evaluation.

• Brand Name: LUTONIX 035 DRUG COATED BALLOON PTA CATHETER
• Common Device Name: DRUG COATED BALLOON PTA CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (GFO); 289 bay road; queensbury NY 12804
• MDR Report Key: 8261135
• Report Number: 3006513822-2019-00005
• Device Sequence Number: 2462970
• Product Code: ONU
• UDI-Device Identifier: 00801741122873
• UDI-Public: (01)00801741122873
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P130024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/06/2020
• Device Model Number: 9004
• Device Catalogue Number: LX35756605F
• Device Lot Number: GFBW0341
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Initial Date Received by Manufacturer: 12/19/2018
• Supplement Date Received by Manufacturer: 03/25/2019
• Initial Report FDA Received Date: 01/18/2019
• Supplement Report FDA Received Date: 03/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Hospitalization
• Patient Age: 74 YR
• Patient Weight: 59