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

Model Number H7493918438300

Device Problem Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/25/2017

Event Type  malfunction  

Manufacturer Narrative

Device is a combination product.Age at time of event: 18 years or older.(b)(4).Device evaluated by mfr.: a stent delivery system was returned for analysis.A visual examination of the stent found that the first proximal stent row was damaged with stent struts lifted on one side.The undamaged crimped stent outer diameter was measured and was within maximum crimped stent profile measurement.The tip was visually and microscopically examined and damage and stretching were noted.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 device found multiple hypotube kinks along the full length of the catheter.This type of damage is consistent with excessive force being applied to the delivery system.A visual and tactile examination of the inner and outer lumen and mid-shaft section of the shaft polymer extrusion found inner kinking and twisting 2 mm distal from the bi-component bond.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 (b)(6) 2017.It was reported that crossing difficulties were encountered.Vascular access was obtained via the femoral artery.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified left anterior descending artery.A 3.00x38mm promus element¿ plus drug-eluting stent was advanced but failed to cross the lesion.The procedure was completed with a different device.No patient complications were reported and the patient's status was stable.However, returned device analysis revealed a 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: 7140883
• MDR Text Key: 95746938
• Report Number: 2134265-2017-12588
• 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,consum
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/16/2017
• Device Model Number: H7493918438300
• Device Catalogue Number: 39184-3830
• Device Lot Number: 19429131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2016
• 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