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

Model Number UNK651

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

Patient Problems Atrial Tachycardia (1731); Obstruction/Occlusion (2422)

Event Date 05/27/2015

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: 2134265-2016-05314, 2134265-2016-05316 and 2134265-2016-05318.(b)(6).It was reported that stent malposition, intermittent bigeminal and paroxysmal atrial tachycardia and jailing of the diagonal branch occurred.In (b)(6) 2015, the patient was diagnosed with unstable angina and underwent an elective percutaneous coronary intervention (pci).The target lesion was a de novo lesion located in the mid left anterior descending (mlad) artery with 70% stenosis.It was 28 mm long, with a reference vessel diameter of 2.75 mm.The most distal cass site was not reported.There was moderate calcification.Prior to stent insertion, cutting balloon angioplasty was employed due to calcification.A 2.5 x 6 mm cutting balloon was advanced to the mlad and slowly inflated to 7 atmospheres.Repeat cutting balloon angioplasty was performed just distal to the first mlad cut at 6 atmospheres.The target lesion was treated with insertion of 2.75x16mm promus premier¿ drug-eluting stent and 2.75x12mm promus premier¿ drug-eluting stent in an overlapping manner.Post-dilatation was performed (diameter of largest balloon = 3.5 mm; 18 atmospheres).There was 0% residual stenosis.After deployment of the 2.75 x 16 mm stent in the mid-lad, repeat optical coherence tomography (oct) imaging showed there was an additional diseased segment distal to the stented segment, with a minimum luminal area of 2.36 mm2.It also showed that there was only a slightly malposed segment of the proximal mid-lad stent.Therefore, the first stent was post-dilated with a 3.25 x 8 mm nc quantum balloon up to 17 atmospheres.The 2nd stent was overlapped by ~1 mm and deployed to 12 atm.There was some intermittent bigeminy and paroxysmal atrial tachycardia during the balloon inflations and stent deployment in the mid-lad, but these resolved at the end of the case.The post-intervention oct imaging revealed adequate stent apposition of the wall.There were no complications.The patient was discharged on the same day on aspirin and clopidogrel.In (b)(6) 2015, cardiac catheterization revealed jailing of the first diagonal branch with 60% ostial stenosis range.Timi flow 3 was maintained in both the diagonal branch and the lad.Medical therapy was recommended.

• Brand Name: NC QUANTUM APEX BALLOON CATHETER
• Type of Device: CATHETERS, 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 Key: 5726725
• MDR Text Key: 47454145
• Report Number: 2134265-2016-05319
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121667
• 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: 05/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK651
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/19/2016
• 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): Other
• Patient Age: 45 YR