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

Model Number H7493911316350

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/16/2018

Event Type  malfunction  

Manufacturer Narrative

Device is a combination product.(b)(4).

Event Description

It was reported that stent damage occurred.The target lesion was located in a coronary vessel.A 3.50x16mm promus element¿ stent was advanced to treat the target lesion.However, it was noted that the delivery system was kinked and the tip of the stent strut was deformed.The procedure was completed with another of the same device.No patient complications were reported and the patient¿s status was stable.

Manufacturer Narrative

Device evaluated by mfr: stent delivery system was returned for analysis.A visual and microscopic examination of the stent found damage to distal stent rows 3-5.The undamaged crimped stent outer diameter was measured and the result was within maximum crimped stent profile measurement.The tip was visually and microscopically examined and no damage was 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 a hypotube kink 283mm distal from the distal end of the strain relief.A visual and tactile examination of the outer and inner lumen and mid-shaft section found no issues with the polymer extrusion.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 & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).

Event Description

It was reported that stent damage occurred.The target lesion was located in a coronary vessel.A 3.50x16mm promus element stent was advanced to treat the target lesion.However, it was noted that the delivery system was kinked and the tip of the stent strut was deformed.The procedure was completed with another of the same device.No patient complications were reported and the patient¿s status was stable.

• 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: 7578722
• MDR Text Key: 110380713
• Report Number: 2134265-2018-05075
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: CN
• 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,Followup
• Report Date: 05/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/19/2019
• Device Model Number: H7493911316350
• Device Catalogue Number: 39113-1635
• Device Lot Number: 0021179799
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/20/2017
• 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