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

Model Number UNK731

Device Problem Device Slipped (1584)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/16/2015

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 relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

Same case as mdr id# 2134265-2016-06541.(b)(6) clinical study.It was reported that balloon positioning problems were encountered.In (b)(6) 2012, the patient presented due to stable angina and cardiac catheterization was performed.Target lesion #1 was a de novo lesion located in the proximal right coronary artery (rca) with 90% stenosis and was 12mm long with a reference vessel diameter of 3.00mm.Target lesion #1 was treated with pre-dilatation and placement of a 4.00x16mm promus element plus drug-eluting stent, with 0% residual stenosis.Target lesion #2 was a de novo lesion located in the mid rca with 70% stenosis and was 10.00mm long with a reference vessel diameter of 4.00mm.Target lesion #2 was treated with pre-dilatation and placement of a 4.00x12mm promus element plus drug-eluting stent, with 0% residual stenosis.Target lesion #3 was a de novo lesion located in the right posterior descending artery (r-pda) with 80% stenosis and was 10.00mm long with a reference vessel diameter of 3.50mm.Target lesion #3 was treated with pre-dilatation and placement of a 3.50x12mm promus element plus drug-eluting stent, with 0% residual stenosis.Post-deployment of the study stents, coronary artery spasm was noted which was treated with the administration of intracoronary nitroglycerin.The following day, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2015, the patient presented with complaints of worsening shortness of breath and chest pressure which radiates to bilateral arms.Subsequently, the patient was diagnosed with coronary artery disease, was hospitalized, and coronary angiography was performed on the same day.The 70% isr located in the proximal rca was treated with dilatation using a 3.5 x 12.00mm emerge balloon catheter.However, repeated watermelon seeding was noted.Subsequently, cutting balloon angioplasty was performed with a 3.5 x 10.00mm balloon, resulting in less than 30% residual stenosis.The following day, the event was considered resolved and the patient was discharged on aspirin and clopidogrel.

• Brand Name: EMERGE
• 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: 5826608
• MDR Text Key: 50574385
• Report Number: 2134265-2016-06561
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113220
• 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: 06/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNK731
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/30/2016
• 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: N
• Patient Sequence Number: 1
• Patient Age: 65 YR