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

Model Number H7493918428400

Device Problems Kinked (1339); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/08/2017

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.Device is a combination product.(b)(4).Device evaluated by mfr: a promus element plus ous, mr 4.0x28mm, stent delivery system (sds) was returned for analysis.A visual examination of the crimped stent found proximal struts 1 & 2 were lifted.It is likely the crimped stent may have encountered resistance & subsequent damage during the attempt to withdraw the device.The undamaged stent outer diameter (od) was measured and is within the maximum crimped stent specification, indicating that there were no issues with the crimp stent profile.A visual examination of the balloon showed that the balloon cones were reviewed and no issues were noted.A visual and tactile examination found no issue with the shaft polymer extrusion.The bi-component bond showed no signs of damage or strain.A visual and tactile examination of the device found a hypotube break at approximately 260mm distal to the distal end of the strain relief.There were also multiple severe hypotube kinks along the full catheter length.The kinks may have occurred due to the application of excessive force.A visual and tactile examination found no damage to the tip.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 investigation conclusion is operational context as the product meets the design and manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).

Event Description

Reportable based on analysis completed on 11-dec-2017.It was reported that advancing difficulties and shaft kink were encountered.The target lesion was located in the tortuous anatomy left main left anterior descending (lad) artery.After a 6f femoral guiding catheter was engaged, a 4.00x28mm promus element¿ plus drug-eluting stent was advanced to treat the lesion.However, while advancing, the device was stuck in the guiding catheter and when the physician pushed the device further, the shaft was kinked.The stent delivery system was then retrieved and the procedure was completed with a non-bsc stent.No patient complications were reported and the patient's status was stable.However, returned device analysis revealed proximal stent damage and hypotube break.It was further reported that the shaft kinked was noticed upon retrieval of the stent delivery system and it was intact when removed from the patient.

• 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: 7151842
• MDR Text Key: 96023460
• Report Number: 2134265-2017-12681
• 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,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/24/2017
• Device Model Number: H7493918428400
• Device Catalogue Number: 39184-2840
• Device Lot Number: 19446182
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/22/2016
• 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