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

Model Number	9010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bradycardia (1751); Low Blood Pressure/ Hypotension (1914)
Date of Event	05/10/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Analysis: the sample was not returned from the user facility; therefore, a device evaluation is unable to be performed.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.Conclusion: the actual sample was not received for evaluation.The dhr found nothing to indicate a manufacturing related cause for this event.In the opinion of the physician, he is unsure if the occurrence of hypotension and bradycardia is related to the treatment of the lutonix dcb.The patient was previously treated, approximately two years ago, with a lutonix dcb in the same location, and the patient did not have any issues at that time.Furthermore, the patient's predilatation involved atherectomy, which may have contributed to the distal embolization.Reportedly, a clot was noted below the placed filter, which was removed through aspiration.Based on the instructions for use (ifu), the occurrence of hypotension and arrhythmias are inherent risks of any pta procedure.If additional information becomes known to the manufacturer, a supplemental report will be provided with all relevant information.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 that, allegedly, the patient experienced hypotension and bradycardia while the target lesion was being treated with a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter.The health care professional (hcp) used a contralateral approach with a 6 french introducer sheath to access the patient's target lesion located in the superficial femoral artery (sfa).The hcp placed a filter, of unknown type, below the treatment location and proceeded to use a medtronic silver hawk or hawk one device to debulk the sfa.After the atherectomy, a standard cook balloon was used to pre-dilate the target lesion.Reportedly, the lutonix dcb was inflated and held at nominal pressure for two minutes.Allegedly, during the two minute inflation period, the patient¿s blood pressure reportedly dropped by approximately 30 millimeter of mercury.Allegedly, the patient went into bradycardia, of which the rate is unknown.The patient's heart rate and blood pressure were reportedly normal prior to the lutonix dcb inflation.The episode of bradycardia was reportedly "brief, approximately five minutes".The hcp deflated the lutonix dcb, which resulted in the patient's heart rate returning to normal sinus rhythm.It was reported that no dissection or extravasation was found after the treatment with the lutonix dcb.Allegedly, there was some distal embolization below the filter that was removed with a pronto aspiration device.Also, there was a reported clot removed from the distal arteries after the lutonix dcb treatment.The lutonix dcb was removed without complications.The lutonix dcb was requested to be returned for evaluation.No further adverse patient outcomes were reported.In the opinion of the physician, he is unsure if the occurrence of hypotension and bradycardia is related to the treatment of the lutonix dcb.The patient was previously treated approximately two years ago with a lutonix dcb in the same location and the patient did not have any issues at that time.No further adverse patient outcomes were reported.
Event or Problem Description
It was reported that, allegedly, the patient experienced hypotension and bradycardia while the target lesion was being treated with a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter.The health care professional (hcp) used a contralateral approach with a 6 french introducer sheath to access the patient's target lesion located in the superficial femoral artery (sfa).The hcp placed a filter, of unknown type, below the treatment location and proceeded to use a medtronic silver hawk or hawk one device to debulk the sfa.After the atherectomy, a standard cook balloon was used to pre-dilate the target lesion.Reportedly, the lutonix dcb was inflated and held at nominal pressure for two minutes.Allegedly, during the two minute inflation period, the patient¿s blood pressure reportedly dropped by approximately 30 millimeter of mercury.Allegedly, the patient went into bradycardia, of which the rate is unknown.The patient's heart rate and blood pressure were reportedly normal prior to the lutonix dcb inflation.The episode of bradycardia was reportedly "brief, approximately five minutes".The hcp deflated the lutonix dcb, which resulted in the patient's heart rate returning to normal sinus rhythm.It was reported that no dissection or extravasation was found after the treatment with the lutonix dcb.Allegedly, there was some distal embolization below the filter that was removed with a pronto aspiration device.Also, there was a reported clot removed from the distal arteries after the lutonix dcb treatment.The lutonix dcb was removed without complications.The lutonix dcb was requested to be returned for evaluation.No further adverse patient outcomes were reported.In the opinion of the physician, he is unsure if the occurrence of hypotension and bradycardia is related to the treatment of the lutonix dcb.The patient was previously treated approximately two years ago with a lutonix dcb in the same location and the patient did not have any issues at that time.No further adverse patient outcomes were reported.
Additional Manufacturer Narrative
Corrected information: eval code & desc were changed from "3263 and 3317" to "4110, 3331, 4111, and 4114" eval code & desc - conclusion were changed from "92" to "4310" additional information: eval code & desc - result "213" was added.Conclusion added the following statement, "the bd medical advisor as well as a consulting physician reviewed the details of the submitted allegation.Per their review, it is reasonable to suggest the patient experienced a vasovagal response during the 2 minutes the lutonix dcb was inflated.This vasovagal response likely led to the patient's physiological change, which allegedly involved hypotension, with an associated bradycardia" the sample was not returned from the user facility; therefore, a device evaluation is unable to be performed.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.Conclusion: the actual sample was not received for evaluation.The dhr found nothing to indicate a manufacturing related cause for this event.In the opinion of the physician, he is unsure if the occurrence of hypotension and bradycardia is related to the treatment of the lutonix dcb.The patient was previously treated, approximately two years ago, with a lutonix dcb in the same location, and the patient did not have any issues at that time.Furthermore, the patient's predilatation involved atherectomy, which may have contributed to the distal embolization.Reportedly, a clot was noted below the placed filter, which was removed through aspiration.The bd medical advisor as well as a consulting physician reviewed the details of the submitted allegation.Per their review, it is reasonable to suggest the patient experienced a vasovagal response during the 2 minutes the lutonix dcb was inflated.This vasovagal response likely led to the patient's physiological change, which allegedly involved hypotension, with an associated bradycardia.Based on the instructions for use (ifu), the occurrence of hypotension and arrhythmias are inherent risks of any pta procedure.If additional information becomes known to the manufacturer, a supplemental report will be provided with all relevant information.

• Brand Name: LUTONIX 035AV 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: 7571332
• Report Number: 3006513822-2018-00139
• Device Sequence Number: 11059617
• Product Code: PRC
• UDI-Device Identifier: 00801741135392
• UDI-Public: (01)00801741135392
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P170003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2018

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: 01/09/2021
• Device Model Number: 9010
• Device Catalogue Number: LX3575660V
• Device Lot Number: GFCN0501
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/28/2018
• Initial Report FDA Received Date: 06/05/2018
• Supplement Report FDA Received Date: 09/28/2018
• 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: Hospitalization
• Patient Age: 65 YR
• Patient Weight: 68