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

Model Number H7493918424270

Device Problem Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/19/2018

Event Type  malfunction  

Manufacturer Narrative

Device is a combination product.(b)(4).Device evaluated by mfr: promus element plus,mr,ous 2.75x24mm stent delivery system (sds) was returned for analysis.A visual and microscopic examination of the crimped stent identified stent damage.The proximal section of the stent was damaged with stent struts stretched over the proximal balloon cone.The undamaged crimped stent od (outer diameter) was measured and the result was within max crimped stent profile measurement.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 issues.A visual and tactile examination of shaft polymer extrusion revealed no issues.A visual and microscopic examination found damage to the tip.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 operational context as the product meets the design and manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).

Event Description

Reportable based on device analysis completed on (b)(6) 2018.It was reported that crossing difficulties were encountered.Vascular access was obtained via the femoral artery.The target lesion was located in the severely tortuous diagonal branch.Following pre-dilatation, a 2.75x20mm promus element plus drug-eluting stent was advanced but failed to cross the lesion despite a couple of times attempting.A 2.75x24mm promus element plus drug-eluting stent was then advanced but it also failed to cross the lesion.The procedure was completed with a non-bsc device.No patient complications were reported and the patient was doing good.However, returned device analysis revealed proximal stent damage.

• Brand Name: PROMUS ELEMENT¿ PLUS
• 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: 8043849
• MDR Text Key: 126359479
• Report Number: 2134265-2018-07497
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P110010
• 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: 10/16/2018

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: 02/22/2019
• Device Model Number: H7493918424270
• Device Catalogue Number: 39184-2427
• Device Lot Number: 20356273
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/16/2018
• Initial Date FDA Received: 11/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2017
• 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