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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE EMERGE CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

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BOSTON SCIENTIFIC - MAPLE GROVE EMERGE CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number UNK731
Device Problem Difficult to Remove (1528)
Patient Problems Dyspnea (1816); Occlusion (1984); Heart Failure (2206)
Event Date 11/18/2016
Event Type  Injury  
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 relevant information from that review, a supplemental medwatch will be filed. (b)(4).
 
Event Description
Same case as mdr id # 2134265-2017-01185. (b)(4) clinical study. It was reported that catheter entrapment occurred. In (b)(6) 2013, clinical status assessment identified the patient's qualifying condition with stable angina. The patient was also found to have ischemia prior to procedure and was referred for cardiac catheterization. Subsequently, the index procedure was performed. Target lesion #1 was located in the mid left anterior descending artery (lad) with 70% stenosis, a length of 24 mm, and a reference vessel diameter of 3. 0 mm and was treated with pre-dilatation and placement of a 3. 0 x 28 mm study stent with 0% residual stenosis. Target lesion #2 was located in the distal lad with 80% stenosis, a length of 10 mm, and a reference vessel diameter of 2. 5 mm and was treated with pre-dilatation and placement of a 2. 50 x 12 mm study stent. However post study stent deployment, a small flap dissection was noted on the proximal side of the stent. Following post-dilatation, the dissection disappeared and residual stenosis was 0%. Two days later, the patient was discharged on dual antiplatelet medications. In (b)(6) 2016, the patient was transferred for further treatment of worsening heart failure and for transcatheter aortic valve implantation (tavi) assessment. The following day, a 60% proximal stenosis in the lad was noted. The study stents in mid and distal portion were patent. A 99% in stent restenosis of a stent in the proximal portion of the right coronary artery (rca) was also noted. The patient was then referred for percutaneous coronary intervention (pci). Four days after the patient treatment for the heart failure, the 60% stenosis in the left main coronary artery (lmca) to proximal lad was treated with balloon angioplasty and placement of a 3. 5x28mm non-bsc drug eluting stent (des) with 0% residual stenosis and timi 3 flow. A 1. 20mm emerge balloon catheter was advanced to pre-dilate the 99% stenosis of proximal to mid right coronary artery (rca). However, the device was stuck to the calcified post stent stenosis. After successful predilation, a 3. 5mmx38mmpromus premier¿ des was then deployed. The stent was post-dilated with 3. 5x15mm nc emerge balloon catheter and proximally with a 4. 0x15mm nc emerge balloon catheter. However after post dilatation there was some recoil and under-dilation noted in the most proximal part of rca vessel. In addition, the 80% stenosis of 1st obtuse marginal branch (om1) was treated with balloon angioplasty. Post procedure, residual stenosis was 10% with timi 3 flow. Seven days later, the patient was transferred to another hospital for further treatment. In (b)(6) 2016, the patient was discharged on dual antiplatelet medications in consideration of further rehabilitation after three-vessel balloon angioplasty and insertion of three drug stents and subsequent contrast-induced nephropathy.
 
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Brand NameEMERGE
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC - MAPLE GROVE
one scimed place
maple grove MN 55311
Manufacturer Contact
sonali arangil
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key6352812
MDR Text Key68128990
Report Number2134265-2017-01184
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeFI
PMA/PMN Number
K113220
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 01/30/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/23/2017
Is this an Adverse Event Report? Yes
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 Received01/30/2017
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 Treatment Data
Date Received: 02/23/2017 Patient Sequence Number: 1
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