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

Model Number H7493918416300

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 11/13/2017

Event Type  malfunction  

Manufacturer Narrative

Device is combination product.The stent delivery system (sds) was returned for analysis.A visual examination of the stent found no issues on the stent.There were no signs of damage, stretching or lifting of the stent struts.The stent showed no signs of movement and was set equidistant between the proximal and distal markerbands.The crimped stent od (outer diameter) was measured within maximum crimped stent profile measurement.A visual examination of the bumper tip showed no signs of damage.The balloon cones were reviewed and no issues were noted.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.During analysis, brown marks/stains, were observed on two locations inside the balloon body.The two marks/stains were located inside the proximal balloon, on the proximal side of the proximal markerband just under the start of two separate balloon folds.The marks/stains appeared to have bubbles indicating that the stain/mark could have been in liquid form that solidified when it dried.Based on analysis results, the incident that was reported cannot be confirmed as there was no thread or fm that was observed on the stent, however brown marks/stains which appeared to be solidified medium was observed which could potentially be medium most likely used during preparation of the device prior to use.A visual and tactile examination found kinks along the hypotube shaft.A visual and tactile examination of the inner and outer lumen and mid-shaft section found no issues with the extrusion shaft.The bicomponent bond showed no signs of damage.No other issues were identified during the product analysis.The investigation conclusion is not confirmed - returned as there was no evidence of either the alleged issue(s) or any defect which could have contributed to the event.(b)(4).

Event Description

It was reported that the device contained foreign material.During preparation of the 3.00x16mm promus element¿ plus stent, a thread was noticed inside the device.There was no patient involvement.The procedure was completed with another of the same product and the patient is fine.

• Brand Name: PROMUS ELEMENT¿ PLUS
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7099638
• MDR Text Key: 94957019
• Report Number: 2134265-2017-11765
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• PMA/PMN Number: P110010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/02/2019
• Device Model Number: H7493918416300
• Device Catalogue Number: 39184-1630
• Device Lot Number: 21004603
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/30/2017
• 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