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

Model Number H7493911324300

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/13/2018

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 the left coronary artery.A 3.00x24mm promus element stent was advanced to treat the lesion.However, it was noted that the stent struts were lifted.The device was completely removed and 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, eval summary attached, method codes, result codes, conclusion codes updated.Device evaluated by mfr.: promus element mr ous 3.00 x 24mm stent delivery system was returned for analysis.The crimped stent was examined and damage was noted.Proximal strut row 6 was damage with struts lifted and pulled in a distal direction.The remainder of the stent was undamaged.The undamaged crimped stent outer diameter was within max crimped stent profile measurement.The bumper tip of the device was examined and no issues were noted.The balloon cones were reviewed and there were no issues to note.The balloon had not been subjected to any significant positive pressure.A visual and tactile examination of the hypotube revealed no issues.An examination of the shaft polymer extrusion identified no issues.The bi-component bond showed no signs of damage or strain.No 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 the left coronary artery.A 3.00x24mm promus element¿ stent was advanced to treat the lesion.However, it was noted that the stent struts were lifted.The device was completely removed and 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
• MDR Report Key: 7635095
• MDR Text Key: 112309821
• Report Number: 2134265-2018-05953
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• PMA/PMN Number: SIMILAR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 06/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/05/2019
• Device Model Number: H7493911324300
• Device Catalogue Number: 39113-2430
• Device Lot Number: 21379415
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2018
• Initial Date Manufacturer Received: 06/13/2018
• Initial Date FDA Received: 06/25/2018
• Supplement Dates Manufacturer Received: 07/16/2018
• Supplement Dates FDA Received: 08/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1