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

Model Number H7493939920220

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/27/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that stent damage occurred.When advancing a 2.25 x 20mm promus premier select drug-eluting stent to the calcified target lesion, it was noted that the stent was deformed on the proximal part.The procedure was completed with another of the same device.There were no patient complications and the patient's condition was stable.

Event Description

It was reported that stent damage occurred.When advancing a 2.25 x 20mm promus premier select drug-eluting stent to the calcified target lesion, it was noted that the stent was deformed on the proximal part.The procedure was completed with another of the same device.There were no patient complications and the patient's condition was stable.

Manufacturer Narrative

Device evaluated by mfr, eval summary attached, method codes, results codes, conclusion codes: updated.Device evaluated by mfr: stent delivery system was returned for analysis.A visual examination of the stent found that the proximal end of the stent was damaged with stent struts pushed and bunched in a distal direction.The distal end of the stent was noted to be still in its crimped position.The undamaged section of the crimped stent outer diameter was measured and was within specification.The tip was visually and microscopically examined and signs of damage were noted at the distal edge of the tip.This type of damage most likely occurred when the tip was pushed against a restriction.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 found no kinks or damage on the hypotube shaft.A visual and tactile examination of the inner and outer lumen and mid-shaft section 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 investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).

• Brand Name: PROMUS PREMIER SELECT
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7616621
• MDR Text Key: 111673914
• Report Number: 2134265-2018-05381
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 05/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/08/2020
• Device Model Number: H7493939920220
• Device Lot Number: 21601475
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2018
• Date Manufacturer Received: 06/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1