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

Model Number H7493911328250

Device Problems Kinked (1339); Failure to Advance (2524)

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).Device evaluated by mfr: the stent delivery system (sds) was returned for analysis.A visual examination of the stent found that on proximal stent strut rows 1 and 2, stent struts were lifted and pulled distally.The undamaged section of the crimped stent outer diameter (od) was measured and is within maximum crimped stent profile measurement.Stent damage most likely occurred during withdrawal attempts.The tip was visually and microscopically examined and no signs of damage 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 no kinks along the hypotube shaft.A visual and tactile examination of the inner and outer lumen and mid-shaft found no issues with the extrusion shaft.The bicomponent 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 investigation conclusion is not confirmed - returned as there was no evidence of either the alleged issue(s) or any defect which could have contributed to the event.(b)(4).

Event Description

Reportable based on device analysis completed on 16-jun-2018.It was reported that shaft kinked and crossing difficulties were encountered.Vascular access was obtained via femoral artery.The concentric target lesion containing an acute angle was located in the mildly calcified left circumflex artery.The lesion contained >=90 degrees bend.A 2.50x28mm promus element¿ drug-eluting stent was advanced to treat the lesion.However, it was noted that the shaft was kink and the device was unable to cross the lesion.The device was removed and the procedure was completed with a different stent with the help of support wire.No patient complications were reported and the patient's status was stable and good.The patient is doing well.However, returned device analysis revealed proximal stent damage.

• 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: 7653024
• MDR Text Key: 112849002
• Report Number: 2134265-2018-05994
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 06/16/2018

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: 02/25/2019
• Device Model Number: H7493911328250
• Device Catalogue Number: 39113-2825
• Device Lot Number: 21089661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/16/2018
• 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
• Patient Age: 44 YR
• Patient Weight: 62