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

Model Number H7493911312220

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/19/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the stent damage occurred.The target lesion was located in the left coronary artery.A 2.25x12mm promus element ¿ drug-eluting stent was advanced to treat the lesion.However, it was noted that the stent strut was lifted.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.

Event Description

It was reported that the stent damage occurred.The target lesion was located in the left coronary artery.A 2.25x12mm promus element ¿ drug-eluting stent was advanced to treat the lesion.However, it was noted that the stent strut was lifted.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 2.25 x 12mm stent delivery system was returned for analysis.A visual examination of the stent identified damage.Strut segments from the midsection of the stent to the proximal end of the stent were lifted, misaligned and stretched in a proximal direction.The remainder of the struts were undamaged.The undamaged crimped stent outer diameter (od) was measured and is within max crimped stent profile measurement.The bumper tip of the device was examined and 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 hypotube revealed a hypotube kink as the distal end of the strain relief.An examination of the shaft polymer extrusion identified no issues.The bi-component bond showed no signs of damage or strain.No other issues were identified during the product analysis.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).

• Brand Name: PROMUS ELEMENT ¿
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7652416
• MDR Text Key: 112849621
• Report Number: 2134265-2018-06170
• 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: 06/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2018
• Device Model Number: H7493911312220
• Device Catalogue Number: 39113-1222
• Device Lot Number: 0020746791
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2018
• Date Manufacturer Received: 07/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1