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Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Patient Problem/Medical Problem (2688)
Event Date 01/26/2019
Event Type  Death  
Manufacturer Narrative
Age or date of birth: average age. Sex: majority gender. Outcomes to adverse event, event date: article publish date. "drug-eluting balloon angioplasty versus uncoated balloon angioplasty for the treatment of in-stent restenosis of the femoropopliteal arteries. " cochrane database of systematic reviews 2019, issue 1. Art. No. : cd012510. Doi: 10. 1002/14651858. Cd012510. Pub2. If information is provided in the future, a supplemental report will be issued.
Event Description
Background: stents are placed in the femoropopliteal arteries for numerous reasons, such as atherosclerotic disease, the need for dissection, and perforation of the arteries, and can become stenosed with the passage of time. When a stent develops a flow-limiting stenosis, this process is known as ¿in-stent stenosis. ¿ it is thought that in-stent restenosis is caused by a process known as ¿intimal hyperplasia¿ rather than by the progression of atherosclerotic disease. Management of in-stent restenosis may include performing balloon angioplasty, deploying another stent within the stenosed stent to force it open, and creating a bypass to deliver blood around the stent. The role of drug-eluting technologies, such as drug-eluting balloons (debs), in the management of in-stent restenosis is unclear. Drug-eluting balloons might function by coating the inside of stenosed stents with cytotoxic chemicals such as paclitaxel and by inhibiting the hyperplastic processes responsible for in-stent restenosis. It is important to perform this systematic review to evaluate the efficacy of deb because of the potential for increased expenses associated with debs over uncoated balloon angioplasty, also known as plain old balloon angioplasty (poba). Event description: 263 patients participated in clinical trials for deb. Inpact admiral and admiral xtreme were used in fair trial. Pacific xtreme and inpact admiral were used in the isar-pebis trial. No medtronic device was used in pacuba trial. The devices were used to treat the superficial femoral artery and femoral popliteal arteries. The patients have a history of pad, in-stent restenosis, re-occlusion, diabetes. Ischemia and foot infection. The vessels were pre-dilated with inflation time of 2 mins. None of the studies reported amputation free survival and no major or minor lower extremity amputations were reported at the one, six, twelve or twenty-four month follow ups. None of the studies reported late lumen loss. Postoperatively: participants received aspirin 100 mg/d indefinitely and clopidogrel 75 mg/d for at least 6 months the patients presented post procedure with two target lesion revascularisations (tlr) from the isar pebis trial only at the six and the twelve month follow up. There was no tlr reported in the fair trial. The fair and isar pebis trial reported one case of restenosis each at six months follow up. The fair trial reported one case of restenosis at the twelve month follow up. The fair and isar pebis trial reported one death each at the six month follow up. The fair trial reported a death at the twelve month follow up. The isar pebis trial reported one death at the twenty-four month follow up. Bail out stenting, medication, hospitalization and , re-occlusion were also reported as outcomes from this study. Objectives: to assess the safety and efficacy of debs compared with uncoated balloon angioplasty in people with in-stent restenosis of the femoropopliteal arteries as assessed by criteria such as amputation-free survival, vessel patency, target lesion revascularization, binary restenosis rate, and death. We define ¿in-stent restenosis¿ as 50%or greater narrowing of a previously stented vessel by duplex ultrasound.
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Manufacturer (Section D)
via martiri della liberta, 7
roncadelle 25030
IT 25030
Manufacturer (Section G)
via martiri della liberta, 7
roncadelle 25030
IT 25030
Manufacturer Contact
toni o'doherty
parkmore business park west
MDR Report Key8421884
MDR Text Key138831043
Report Number3004066202-2019-00007
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Reporter Occupation
Type of Report Initial
Report Date 03/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/14/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/15/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/14/2019 Patient Sequence Number: 1