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

Model Number H7493911338400

Device Problem Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/01/2017

Event Type  malfunction  

Manufacturer Narrative

Device is a combination product.(b)(4).Device evaluated by mfr: a promus element mr ous 4.00 x 38mm stent delivery system was returned for analysis.A visual examination of the stent revealed proximal stent damage.The first strut on the proximal end was lifted and pulled distally.The undamaged section of the crimped stent outer diameter was measured and 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 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 found no signs of kinks or damage.An examination of the shaft polymer extrusion 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 device analysis completed on 07-apr-2017.It was reported that shaft kink occurred.The target lesion was located in a coronary artery.A 4.00x38mm promus element ¿ long drug eluting stent was advanced to treat the lesion; however, it was noted that the shaft was kinked.No patient complications were reported and the patient's status was stable.However, returned device analysis revealed a proximal stent damage.

• Brand Name: PROMUS ELEMENT ¿ LONG
• 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: 6521852
• MDR Text Key: 73742349
• Report Number: 2134265-2017-03923
• 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: 04/07/2017

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: 01/16/2018
• Device Model Number: H7493911338400
• Device Catalogue Number: 39113-3840
• Device Lot Number: 0019511268
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/07/2017
• Initial Date FDA Received: 04/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2016
• 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