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

Model Number H7493911332300

Device Problem Bent (1059)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/02/2018

Event Type  malfunction  

Manufacturer Narrative

Device is a combination product.(b)(4).Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported that stent damage occurred.Vascular access was obtained via the femoral artery.The 80% stenosed, 35mm in length, concentric, de novo target lesion was located in the non-tortuous and 3.0mm in diameter right coronary artery.Following pre-dilatation with multiple non compliant balloons, a 3.00x32mm promus element¿ was advanced to treat the lesion.However, the device failed to cross the lesion and it was noted that the stent surface was damaged.No patient complications were reported.

Event Description

It was reported that stent damage occurred.Vascular access was obtained via the femoral artery.The 80% stenosed, 35mm in length, concentric, de novo target lesion was located in the non-tortuous and 3.0mm in diameter right coronary artery.Following pre-dilatation with multiple non compliant balloons, a 3.00x32mm promus element was advanced to treat the lesion.However, the device failed to cross the lesion and it was noted that the stent surface was damaged.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr: promus element mr ous 3.00 x 32mm stent delivery system was returned for analysis.A visual examination of the stent identified damage.The proximal end of the stent was damaged and pulled proximally over the proximal markerband.The mid-distal section of the stent was undamaged.The undamaged crimped stent outer diameter was measured and was within maximum 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 revealed no issues.An examination of the shaft polymer extrusion identified 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 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 ELEMENT ¿
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7643251
• MDR Text Key: 112556237
• Report Number: 2134265-2018-05804
• 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: 06/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/11/2018
• Device Model Number: H7493911332300
• Device Catalogue Number: 39113-3230
• Device Lot Number: 20443407
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/04/2018
• Date Manufacturer Received: 07/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 60