MAUDE Adverse Event Report: COOK INC UNKNOWN; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number N/A

Device Problems Other (for use when an appropriate device code cannot be identified) (2203); Appropriate Term/Code Not Available (3191)

Patient Problems Other (for use when an appropriate patient code cannot be identified) (2200); No Code Available (3191)

Event Date 12/26/2014

Event Type  Injury  

Event Description

On (b)(6) 2013, the pt rec'd on 6 x 60 mm stent, deployed in the left external iliac artery.The lesion was not pre-dilated.There was no difficulty deploying the device.Dilation was performed following stent deployment.There was no residual stenosis, thrombus or dissection noted at the end of the procedure.A second stent, measuring 7 x 60 mm, was deployed in the left common iliac artery and overlapped with the first stent.The lesion was not pre-dilated.There was no difficulty deploying the device.There was no residual stenosis, thrombus or dissection noted at the end of the procedure.The core lab noted the following: the first stent was deployed but did not fully cover the more proximal left external iliac artery lesion, so a second stent was deployed, overlapping the first, covering the second lesion and extending into the left common iliac artery.The area of overlap was post-dilated by the balloon that deployed the second stent.The post-dilation was only performed in the area of overlap with the first stent.On (b)(6) 2013 (one day post-procedure), the ultrasound revealed patency proximal to, within, and distal to the study lesion.Core lab analysis concurred with this assessment.No adverse events were reported during the hospitalization.The pt was discharged on (b)(6) 2013.The following adverse events have been reported for this pt: on (b)(6) 2013 (14 days post-procedure) - right leg claudication/rest pain.An atherectomy and a balloon angioplasty were performed to the right sfa and cfa extending into the right external iliac artery.(b)(6) 2014 (161 day post-procedure) - worsened claudication/rest pain involving both right and left sfas.The balloon angioplasty and atherectomy were performed and a stent was placed in the right sfa.A balloon angioplasty was performed and a stent was placed in the left sfa.On (b)(6) 2014 (246 days post-procedure), core lab analysis of the 9-month follow-up ultrasound showed patency proximal to, within and distal to both study lesions.On (b)(6) 2014 (498 days post-procedure) - worsened claudication/rest pain involving the study lesion and the left sfa.A balloon angioplasty was performed to the study lesion to treat restenosis.The intervention was performed at a non-study site by a non-study physician.An atherectomy and balloon angioplasty were performed to the left sfa.On (b)(6) 2015 (519 day post-procedure), the pt was hospitalized for angina requiring intervention.And angioplasty and stent placement were performed.

Manufacturer Narrative

(b)(4).The event is currently under investigation.

Manufacturer Narrative

(b)(4).Event evaluation: a review of complaint history, device history record, instructions for use (ifu) and trends was conducted during the investigation.The product was not returned for evaluation.The device is supplied with an instructions for use; which lists restenosis as a potential adverse event.There is no evidence to suggest that product was not manufactured to current specifications.Patient presented with many preexisting conditions that could have lead to event.Patient also had other similar events not in the stented region.Quality engineering risk assessment assessed the risk to patient and concluded that with the addition of this complaint, the risk remains acceptable and no risk mitigation actions are required.We will continue our monitoring of similar complaints and have notified the appropriate internal personnel of this event.(b)(4).Event evaluation: a review of complaint history, device history record, instructions for use (ifu) and trends was conducted during the investigation.The product was not returned for evaluation.The device is supplied with an instructions for use; which lists restenosis as a potential adverse event.There is no evidence to suggest that product was not manufactured to current specifications.Patient presented with many preexisting conditions that could have lead to event.Patient also had other similar events not in the stented region.Quality engineering risk assessment assessed the risk to patient and concluded that with the addition of this complaint, the risk remains acceptable and no risk mitigation actions are required.We will continue our monitoring of similar complaints and have notified the appropriate internal personnel of this event.

Event Description

On (b)(6) 2013, the (b)(6) female patient received one 6 x 60 mm stent, deployed in the left external iliac artery.The lesion was not pre-dilated.There was no difficulty deploying the device.Dilatation was performed following stent deployment.There was no residual stenosis, thrombus or dissection noted at the end of the procedure.A second stent, measuring 7 x 60 mm, was deployed in the left common iliac artery and overlapped with the first stent.The lesion was not pre-dilated.There was no difficulty deploying the device.There was no residual stenosis, thrombus or dissection noted at the end of the procedure.The core lab noted the following: the first stent was deployed but did not fully cover the more proximal left external iliac artery lesion, so a second stent was deployed, overlapping the first, covering the second lesion and extending into the left common iliac artery.The area of overlap was post-dilated by the balloon that deployed the second stent.Post-dilation was only performed in the area of overlap with the first stent.On (b)(6) 2013 (one day post-procedure), the ultrasound revealed patency proximal to, within, and distal to the study lesion.Core lab analysis concurred with this assessment.No adverse events were reported during the hospitalization.The patient was discharged on (b)(6) 2013.The following adverse events have been reported for this patient: on (b)(6) 2013 (14 days post-procedure) right leg claudication/rest pain.An atherectomy and balloon angioplasty were performed to the right sfa and cfa extending into the right external iliac artery.(b)(6) 2014 (161 days post-procedure) worsened claudication/rest pain involving both right and left sfas.A balloon angioplasty and atherectomy were performed and a stent was placed in the right sfa.A balloon angioplasty was performed and a stent was placed in the left sfa.On (b)(6) 2014 (246 days post-procedure), core lab analysis of the 9-month follow-up ultrasound showed patency proximal to, within and distal to both study lesions.On (b)(6) 2014 (498 days post-procedure) worsened claudication/rest pain involving the study lesion and the left sfa.Balloon angioplasty was performed to the study lesion to treat restenosis.The intervention was performed at a non-study site by a non-study physician.An atherectomy and balloon angioplasty were performed to the left sfa.On (b)(6 2015 (519 days post-procedure), the patient was hospitalized for angina requiring intervention.Angioplasty and stent placement were performed.

• Brand Name: UNKNOWN
• Type of Device: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 4541902
• MDR Text Key: 17577816
• Report Number: 1820334-2015-00082
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,user facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/23/2015,01/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/22/2015
• Event Location: Hospital
• Date Manufacturer Received: 01/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR