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

Model Number H7493911338350

Device Problem Positioning Failure (1158)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/20/2018

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 distal stent rows 1-2 were damaged and misaligned.Proximal stent rows 14-15 were misaligned.The undamaged crimped stent outer diameter (od) was measured and is within maximum crimped stent profile measurement.A visual and microscopic examination of the bumper tip showed signs of damage.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.An encore inflation device was used to carry out functional testing.A vacuum was pulled and the balloon deflated within 3 seconds.The encore inflation device was verified before and after using druck pressure gauge.A visual and tactile examination of the device found no issues along the hypotube.A visual and tactile examination of the device found that there were no issues with the mid shaft, inner or outer polymer extrusion.The device was loaded on a 0.014¿¿ guidewire without issue.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-jul-2018.It was reported that failure of the stent to deploy occurred.The target lesion was located in a coronary artery.A 3.50x38mm promus element¿ long drug-eluting stent was advanced to treat the lesion.However, the stent would not deploy.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.However, returned device analysis revealed 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: 7755341
• MDR Text Key: 116224552
• Report Number: 2134265-2018-06937
• 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: 07/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/22/2019
• Device Model Number: H7493911338350
• Device Catalogue Number: 39113-3835
• Device Lot Number: 0020963598
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2017
• 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