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Model Number UNK731
Device Problem Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/08/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). 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 information from that review, a supplemental medwatch will be filed. (b)(4).
Event Description
Same case as mdr id#: 2134265-2016-11972 and 2134265-2016-11973. (b)(6) clinical study. It was reported that balloon rupture occurred. Prior to the index procedure, heparin or other anticoagulant was given. In (b)(6) 2015, the patient received a loading dose of 81 mg of aspirin and 300mg of clopidogrel. Subsequently, index procedure was performed. A lotus introducer was placed and then the aortic valve was treated with balloon valvuloplasty. Initially, a 23 mm lotus valve was inserted and attempted to be deployed. However, due to undersize of the 23 mm lotus valve, it was not deployed. Hence the 23 mm lotus valve was exchanged for a second 25 mm lotus valve which was successfully deployed. Successful repositioning of the second 25 mm lotus valve involved partial and complete resheathing of the lotus valve in the delivery system catheter and deployment into a more accurate position within the aortic annulus. Retrieval was not attempted. Two days later, the patient was discharged on aspirin, warfarin and clopidogrel. In (b)(6) 2016, the patient presented emergently with complaints of progressive worsening of dyspnea, chest discomfort and along with increased fatigue and the patient was hospitalized on the same day for further evaluation. The patient states that ¿exertional chest pain radiating towards left arm that was progressed from last month, becoming relieved chest pain by 1-2 nitro tablets, occurring multiple times and was symptomatic. ¿ the patient was diagnosed to have experienced non-st segment elevation myocardial infarction (nstemi) and exertional dyspnea secondary to obstructive coronary artery disease. Cardiac catheterization was recommended. At the time of event, the subject was on aspirin and clopidogrel. Two days later, cardiac catheterization was performed and revealed an 80% stenosed, hazy, focal target lesion located in the mid left anterior descending (lad) artery and 90% stenosed target lesion in the heavy calcified ostial right coronary artery (rca). Percutaneous coronary intervention (pci) was recommended. On the same day, a 3. 0x12mm promus premier drug-eluting stent (des) was deployed at 16 atmospheres in the mid lad. Post procedure final angiogram showed no evidence of perforation or dissection with residual stenosis of 0 % and timi 3 flow. No complication was noted. A 2. 0x12mm emerge balloon catheter was then advanced to the rca for predilation. However upon inflation, the balloon ruptured due to heavy calcification. Hence a 2. 0 x 12 mm emerge balloon was then exchanged with a 3. 5 x 12 mm emerge balloon and 4. 0 x 12 mm emerge balloon. However even after repeated attempts at pre-dilatation with a 3. 5 x 12 mm emerge balloon and 4. 0 x 12 mm emerge balloon, both the balloons were ruptured. The decision was made to exchange the above mentioned 2 emerge balloons with a cutting balloon. The 2 emerge balloons were then exchanged for a 2. 75 x 10 mm flextome cutting balloon. However the balloon was unable to cross the lesion. Hence, the cutting balloon was finally exchanged for a 3. 5 x 12 mm non-bsc balloon catheter, which successfully dilated the lesion at 20 atmospheres. A 4. 0x12mm promus premier des was successfully deployed across the lesion. The stent was post dilated with 4. 5x12mm non-compliant balloon. Final angiogram showed no evidence of perforation or dissection. At the time of event, the patient was on aspirin and clopidogrel. The patient was recommended to continue aspirin lifelong and clopidogrel uninterrupted for 12 months; warfarin as well. The following day, the event was considered to be recovered / resolved and the patient was discharged on the same day.
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Brand NameEMERGE
Manufacturer (Section D)
one scimed place
maple grove MN 55311
Manufacturer Contact
sonali arangil
one scimed place
maple grove, MN 55311
MDR Report Key6186504
MDR Text Key62791760
Report Number2134265-2016-11971
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 12/07/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/19/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNK731
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 Received12/07/2016
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