MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY PROMUS ELEMENT? PLUS; STENT, CORONARY, DRUG-ELUTING

Model Number H7493911420300

Device Problem Occlusion Within Device (1423)

Patient Problems Angina (1710); Dyspnea (1816); Thrombosis (2100); Discomfort (2330)

Event Date 04/06/2015

Event Type  Injury  

Event Description

(b)(6) clinical study.It was reported that angina and stent thrombosis occurred.In (b)(6) 2013, the patient presented due to stable angina.Subsequently, coronary angiography and index procedure were performed.The target lesion #1 was a de novo lesion located in the proximal left circumflex (lcx) with 90% stenosis and was 15 mm long with a reference vessel diameter of 3.0 mm.The lesion was treated with direct stent placement using a 3.0 mm x 20 mm promus element¿ plus stent, resulting to 0% residual stenosis.The target lesion # 2 was a de novo lesion located in the left main coronary artery (lmca) with 70% stenosis and was 5 mm long with a reference vessel diameter of 3.0 mm.The lesion was treated with direct stent placement using a 3.0 mm x 8 mm promus element¿ plus stent, resulting to 0% residual stenosis.One day post procedure, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2015, the patient presented emergently with complaints of chest discomfort associated with dyspnea and was hospitalized.The coronary angiography revealed 70% in-stent restenosis (isr) of previously deployed 3.0 mm x 20 mm promus element¿ plus stent in the lcx, which was reported as stent thrombosis by site.The 70-90% stenosis extending from proximal lcx to distal lcx was treated with direct stent placement using 2.75 mm x 12 mm, 3.00 mm x 12 mm and 3.0 mm x 23 mm non-bsc drug eluting stents.The event was considered as not resolved at the time of reporting.Two days post procedure, the patient was discharged on aspirin and clopidogrel.

Manufacturer Narrative

Device is a combination product.Device evaluated by mfr: it is indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.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).

• Brand Name: PROMUS ELEMENT? PLUS
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 4743059
• MDR Text Key: 5883676
• Report Number: 2134265-2015-02671
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/10/2013
• Device Model Number: H7493911420300
• Device Catalogue Number: 39114-2030
• Device Lot Number: 0015796615
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/22/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 67 YR