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

Model Number H7493911328270

Device Problem Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/28/2017

Event Type  malfunction  

Manufacturer Narrative

Device is a combination product.(b)(4).Promus element,mr,ous 2.75x28mm stent delivery system (sds) was returned for analysis.A visual and microscopic examination of the crimped stent found no issues with 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 between the proximal and distal marker bands.The crimped stent od (outer diameter) was measured and the result was within maximum crimped stent profile measurement.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.A visual and tactile examination of the hypotube found multiple hypotube kinks along the full length of the catheter.A visual and tactile examination of shaft polymer extrusion revealed a shaft break at the site of the port bond.A visual and microscopic examination found no damage to the tip.No other issues were identified during the product analysis.The investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).

Event Description

Reportable based on device analysis completed on 15-oct-2018.It was reported that difficulties tracking over the guide wire were encountered.Vascular access was obtained via the right femoral artery.The 70-80% stenosed, 2.5mm x 24mm, concentric, de novo target lesion with a bend of between 45 and 90 degrees was located in the severely tortuous and mildly calcified right coronary artery.After a 6f non-bsc was engaged coaxially and a non-bsc guide wire was advanced, pre-dilatation was performed with a 1.5 x 12 non-bsc balloon catheter.Subsequently, a 2.75x28mm promus element ¿ drug-eluting stent was advanced but the device did not track over the wire.The device was removed and advanced again with a support wire but the device was still unable to track.The device was removed and the procedure was completed with another of the same device with good final outcome.No patient complications were reported and the patient's status was stable.However, returned device analysis revealed a shaft polymer extrusion break.

• Brand Name: PROMUS ELEMENT ¿
• 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: 8034949
• MDR Text Key: 126083158
• Report Number: 2134265-2018-07495
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: SIMILAR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H7493911328270
• Device Catalogue Number: 39113-2827
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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 Age: 49 YR