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

Model Number H7493911316300

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/24/2018

Event Type  malfunction  

Manufacturer Narrative

Device is a combination product.Age at time of event: 18 years or older.(b)(4).

Event Description

It was reported that stent damage occurred.Vascular access was obtained via the femoral artery.The 90% stenosed, 16mm x 3.00mm target lesion was located in the severely tortuous and severely calcified left anterior descending artery.A 3.00x16mm promus element ¿ stent was advanced to treat the lesion.However, the stent could not pass the lesion and it was observed that the stent was damaged.The device was removed from the patient and the procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.

Event Description

It was reported that stent damage occurred.Vascular access was obtained via the femoral artery.The 90% stenosed, 16mm x 3.00mm target lesion was located in the severely tortuous and severely calcified left anterior descending artery.A 3.00x16mm promus element stent was advanced to treat the lesion.However, the stent could not pass the lesion and it was observed that the stent was damaged.The device was removed from the patient and the procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.

Manufacturer Narrative

Device evaluated by mfr.: promus element mr ous 3.00 x 16mm stent delivery system was returned for analysis.A visual examination of the stent identified no issues.The stent showed no signs of damage or movement and was set equidistant between the proximal and distal markerbands.The undamaged crimped stent od (outer diameter) was measured and the result was within max 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 a break at 225mm distal to the distal end of the strain relief.There were also multiple hypotube kinks noted.An examination of the shaft polymer extrusion identified multiple midshaft kinks.The bicomponent bond showed no signs of damage or strain.No other issues were identified during the product analysis.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).

• Brand Name: PROMUS ELEMENT ¿
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7659864
• MDR Text Key: 113272814
• Report Number: 2134265-2018-05960
• 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: 06/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/05/2019
• Device Model Number: H7493911316300
• Device Catalogue Number: 39113-1630
• Device Lot Number: 0021362226
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2018
• Date Manufacturer Received: 07/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1