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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC - MAPLE GROVE APEX BALLOON CATHETER CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number UNK21
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bradycardia (1751); Low Blood Pressure/ Hypotension (1914)
Event Date 12/02/2015
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
(b)(6). It was reported that bradycardia and hypotension occurred. In (b)(6) 2015, clinical assessment indicated that the patient's qualifying condition was stable angina. During the angiography, there were electrocardiogram (ecg) changes and the patient became acutely hypotensive with each injection of contrast (visapaque). These symptoms were thought to be likely secondary to ischemic burden; however, there was concern for contrast allergy. The patient was given epinephrine and solumedrol, which resolved the symptoms. On the same day, target lesion #1, a de novo lesion, was located in the distal right coronary artery (rca) with 80% stenosis and was 20mm long with a reference diameter of 2. 5mm. Mild calcification and mild vessel tortuosity were present. Target lesion #1 was treated with pre-dilation and placement of a 2. 50x28mm promus premier everolimus-eluting platinum chromium coronary stent. Post-dilation was performed with 0% residual stenosis. Target lesion #2, due to in-stent restenosis of a bare-metal stent (bms), was located in the mid rca to the distal rca with 70% stenosis and was 36mm long with a reference diameter of 3. 5mm. Target lesion #2 was treated with direct placement of a 3. 50x38mm promus premier everolimus-eluting platinum chromium coronary stent. Post-dilation was not performed, and there was 0% residual stenosis. Repeat angiography revealed good stent apposition, stent expansion, with thrombolysis in myocardial infarction (timi) 3 flow and no sign of distal disease or trauma. The patient had no further ecg changes or hypotension with injection. One day post procedure, the patient was discharged on aspirin and ticagrelor. In (b)(6) 2015, the patient experienced worsening of coronary artery disease which required intervention of a percutaneous coronary intervention (pci) in the distal rca to the right posterior descending artery (rpda) and a target vessel revascularization (tvr). During the procedure, a 2. 5x12mm apex balloon catheter was advanced and seated across the lesion, and pre-dilatation balloon angioplasty was performed. The patient developed bradycardia and hypotension similar to an episode during his last coronary angiogram. Epinephrine, intravenous (iv) fluids, and solu-medrol were administered. The patient slowly regained his pressure with normalization of his heart rate. The decision was made to continue with the pci. The patient underwent a successful pci with a 3. 0x15mm non-bsc drug-eluding stent deployed to a non-target lesion in the distal rca to the rpda followed by post-dilation. Pre-treatment stenosis was 90%, and post-treatment stenosis was 0%. Following the pci, the patient was admitted to the cardiology service overnight due to the hypotension experienced during his pci. The patient denied any chest pain, shortness of breath, nausea, vomiting, diaphoresis, orthopnea, paroxysmal nocturanal dyspnea (pnd), and lower extremity (le) edema. His blood pressures remained normal throughout admission. One day post procedure, the coronary artery disease was considered resolved and the patient was discharged.
 
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Brand NameAPEX BALLOON CATHETER
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC - MAPLE GROVE
one scimed place
maple grove MN 55311
Manufacturer Contact
linda leimer
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key5674999
MDR Text Key45746836
Report Number2134265-2016-04288
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P860019
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 04/25/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/24/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberUNK21
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 Received04/25/2016
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

Patient Treatment Data
Date Received: 05/24/2016 Patient Sequence Number: 1
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