MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY CUTTING BALLOON; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number UNK103

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Vasoconstriction (2126)

Event Date 12/17/2015

Event Type  Injury  

Manufacturer Narrative

Device evaluated by mfr.: it is indicated that the device will not be returned for evaluation.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

Same case as mdr id #: 2134265-2016-00019; 2134265-2015-09377; 2134265-2016-00294; 2134265-2016-00293.(b)(4).It was reported that myocardial infarction (mi) and in-stent restenosis (isr) occurred.In (b)(6) 2013, the patient was presented with unstable angina and was referred for cardiac catheterization.Subsequently, index procedure were performed.The first target lesion was located in the mid right coronary artery (rca)with 75% stenosis and was 30 mm long with a reference vessel diameter of 3.0 mm.The lesion was treated with direct stent placement using a 3.00mmx38mm promus element plus drug-eluting stent.However, a dissection occurred which was then treated with placement of a 3.00mmx16mm promus element plus drug-eluting stent which overlapped proximally, resulting to 0% residual stenosis.The second target lesion was located in the distal left anterior descending (lad) artery with 75% stenosis and was 15 mm long with a reference vessel diameter of 2.5 mm.The lesion was treated with direct stent placement using a 2.50mmx20mm promus element plus drug-eluting stent.Following post-dilatation resulting to 0% residual stenosis.One day post procedure, the patient was discharged on aspirin and prasugrel.In (b)(6) 2015, the patient experienced unstable angina and target lesion revascularization was performed in the distal lad with promus element 2.5x8mm and a non-bsc stent in (b)(6) 2015, the patient presented with left sided chest pain and was hospitalized on the same day.The patient was then referred for cardiac catheterization.Elevated troponin values were observed and site reported an event of mi.Subsequently, coronary angiography revealed 50% stenosis in the mid lad, 90% in-stent restenosis (isr) of distal study stents and 50% ostial stenosis in second diagonal branch.Three days post-hospitalization, a 182cm choice floppy guidewire was directed down the mid lad by ballooning with a 2.50x20mm maverick balloon catheter and a 2.25x15mm cutting balloon catheter with some diffused spasm of the vessel noted post-treatment which was relieved with an intracoronary nitroglycerin.Subsequently, a 2.5x20mm promus premier drug-eluting was placed and balloon angioplasty was performed in mid lad resulting from 99% to 0% restenosis.Six days later, the patient complained of repeat chest discomfort and was brought back to cath lab.Coronary angiography revealed mild to moderate narrowing from intimal hyperplasia in the distal third of the stent segment.Isr in the distal lad was treated with cutting balloon angioplasty.On the following day, the event was considered resolved and the patient was discharged on aspirin and prasugrel.

• Brand Name: CUTTING BALLOON
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5366593
• MDR Text Key: 35966405
• Report Number: 2134265-2016-00289
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/11/2016

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
• Device Operator: Health Professional
• Device Model Number: UNK103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/11/2016
• Initial Date FDA Received: 01/14/2016
• 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): Hospitalization; Required Intervention
• Patient Age: 65 YR