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

Model Number H7493911316250

Device Problem Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/17/2017

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 mr ous 2.50 x 16 mm stent delivery system was returned for analysis.A visual examination of the stent found severe stent damage.Stent strut rows 1-6 from the proximal end of the stent appear undamaged; the remainder of the struts are damaged, stretched and pulled in a distal direction extending over the distal end of the tip.The stent was moved from the original crimped position in a distal direction 1.5 mm from the proximal markerband.The manufacturing crimp data for this device was reviewed.The maximum crimped stent profile was found to be within max crimped stent profile measurement.The bumper tip of the device was examined and no issues were noted.The balloon body was reviewed and no issues were noted with the overall balloon.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.A visual and tactile examination of the hypotube profile found no issues.An examination of the shaft polymer extrusion profile found no issues.The bi-component bond showed no signs of damage or strain.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 root cause is not confirmed as there was no evidence of the alleged issue or any anomalies which could have contributed to the reported difficulty.(b)(4).

Event Description

Reportable based on analysis completed on 14mar2017.It was reported that shaft kink occurred.The target lesion was located in a coronary artery.A 2.50 x 16 mm promus element ¿ stent was advanced to treat the lesion.However, during procedure, it was noted that the delivery shaft was kinked.No patient complications were reported and the patient's status was stable.However, returned device analysis revealed stent moved on balloon and stent damaged.

• 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: 6439643
• MDR Text Key: 71052787
• Report Number: 2134265-2017-02633
• 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
• Report Date: 03/14/2017

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: 05/16/2017
• Device Model Number: H7493911316250
• Device Catalogue Number: 39113-1625
• Device Lot Number: 18666929
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/14/2017
• Initial Date FDA Received: 03/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2015
• 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