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

Model Number 9548

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/01/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: used first day of the month of the aware date since event date not provided.Device is a combination product.A promus premier ous mr 12 x 3.00mm stent delivery system (sds) was returned for analysis with a haemostatic valve which had a stent inside the valve.The stent was removed from the haemostatic valve.The stent had been separated from the delivery system and was damaged; it did not appear to have been expanded.The balloon was folded and did not appear to have been inflated.A visual and microscopic examination found no damage to the tip.A visual and tactile examination of the hypotube found multiple hypotube kinks.A visual and tactile examination of the shaft polymer extrusion found no issues.A 0.014 guidewire was loaded via the tip without issues.Due to hardened media inside the device the device inflation could not be carried out and the device was soaked in water bath at 37 degrees celsius for 24hrs.With guidewire loaded the balloon was successfully inflated to rated burst pressure of 16atm using encore inflation device.A vacuum was pulled, and the balloon was deflated in 12 seconds.No other issues were identified during the product analysis.

Event Description

Reportable based on device analysis completed on 06-sep-2019.It was reported that a 12 x 3.00mm promus premier drug-eluting stent had a defect.However, returned device analysis revealed a detached and damaged stent inside a hemostatic valve.

• Brand Name: PROMUS PREMIER
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 9126555
• MDR Text Key: 160313113
• Report Number: 2134265-2019-11538
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 09/26/2019

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: 04/26/2019
• Device Model Number: 9548
• Device Catalogue Number: 9548
• Device Lot Number: 0020603324
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2019
• Initial Date Manufacturer Received: 09/06/2019
• Initial Date FDA Received: 09/26/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2017
• 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