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

Model Number H7493911320220

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

Patient Problems Death (1802); Pulmonary Edema (2020)

Event Date 01/20/2015

Event Type  Death  

Event Description

Same case as (b)(4).Pe-prove clinical study it was reported that the patient died.In (b)(6) 2011, the patient was referred for cardiac catheterization.Target lesion #1 was a de novo lesion located in the distal left anterior descending artery (lad) with 90% stenosis and was 7mm long with a reference vessel diameter of 2.25mm.Target lesion #1 was treated with direct placement of a 2.25x8mm promus element ¿ stent.However after implantation of the stent, it was noted that there was a grade c vessel dissection in the lesion extending distally.The dissection was treated with placement of a 2.25x12mm promus element ¿ stent with 0% residual stenosis.Target lesion #2 was a de novo lesion located in the first obtuse marginal artery (om) with 90% stenosis and was 18mm long with a reference vessel diameter of 2.25mm.Target lesion #2 was treated with direct stent placement using a 2.25x20mm promus element ¿ stent with 0% residual stenosis.Two days post procedure, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2015, the patient died.No corrective actions have been taken for this event.The cause of death is acute pulmonary edema.

Manufacturer Narrative

(b)(6).Device is a combination product.Device evaluated by mfr: the complaint device was not returned for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause was unable to be determined.(b)(4).

• Brand Name: PROMUS ELEMENT ?
• 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: 4946853
• MDR Text Key: 6035701
• Report Number: 2134265-2015-04796
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: SIMILAR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/02/2012
• Device Model Number: H7493911320220
• Device Catalogue Number: 39113-2022
• Device Lot Number: 13681965
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2010
• 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): Death