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

Model Number H7493918420270

Device Problem Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/20/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: stent delivery system (sds) was returned for analysis.A visual examination of the stent found that the stent struts on rows 1 and 2 on the proximal end of stent were lifted and bent distally.The undamaged distal section of the crimped stent outer diameter (od) was measured and is within the maximum crimped stent profile measurement.This type of damage noted most likely occurred during withdrawal attempts.The bumper tip of the device showed no signs of damage.The balloon body was reviewed and no issues were noted with the overall balloon.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.A visual and tactile examination found multiple kinks along the full catheter length.This type of damage is consistent with excessive force being applied to the delivery system.A visual and tactile examination of the outer and mid-shaft section found multiple kinks along the inner and outer extrusion shaft.Visible damage was also noted on the port site entry.The bi-component bond showed no signs of damage or strain.This type of damage is consistent with excessive force being applied to the delivery system.No other issues were identified during the product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical/procedural factors.(b)(4).

Event Description

Reportable based on device analysis completed on 07dec2016.It was reported that crossing difficulties were encountered.  the long target lesion was located in the calcified mid to distal left anterior descending (lad) artery.After pre-dilation was performed using a nc balloon catheter, a 2.75x20mm promus element¿ plus stent catheter was advanced but failed to cross the lesion.  the procedure was completed using another drug-eluting stent (des).No patient complications were reported and the patient's status was stable.However, returned device analysis revealed proximal stent damage.

• 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: 6185360
• MDR Text Key: 62718388
• Report Number: 2134265-2016-11861
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P110010
• 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: 12/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/23/2017
• Device Model Number: H7493918420270
• Device Catalogue Number: 39184-2027
• Device Lot Number: 18883263
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/11/2016
• 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
• Patient Weight: 65