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

Model Number 10671

Device Problems Inflation Problem (1310); Material Rupture (1546)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/16/2021

Event Type  Injury  

Event Description

It was reported that a balloon hole, failure to fully inflate, and additional intervention occurred.A 12 x 3.00 promus elite mr stent was advanced to the target lesion, but it was noticed that there was a hole in it and would not fully inflate.However, the stent was deployed and the stent was fully apposed by using a non compliant (nc) balloon.The procedure was completed.No patient complications resulted in relation to this event and the patient was reported to be stable following the procedure.

Event Description

It was reported that a balloon hole, failure to fully inflate, and additional intervention occurred.A 12 x 3.00 promus elite mr stent was advanced to the target lesion, but it was noticed that there was a hole in it and would not fully inflate.However, the stent was deployed and the stent was fully apposed by using a non compliant (nc) balloon.The procedure was completed.No patient complications resulted in relation to this event and the patient was reported to be stable following the procedure.It was further reported that the target lesion was located in the left anterior descending artery (lad).No patient complications were reported in relation to this event.

Event Description

It was reported that a balloon hole, failure to fully inflate, and additional intervention occurred.A 12 x 3.00 promus elite mr stent was advanced to the target lesion, but it was noticed that there was a hole in it and would not fully inflate.However, the stent was deployed and the stent was fully apposed by using a non compliant (nc) balloon.The procedure was completed.No patient complications resulted in relation to this event and the patient was reported to be stable following the procedure.It was further reported that the target lesion was located in the left anterior descending artery (lad).No patient complications were reported in relation to this event.It was further reported that no other device was present in the vessel.The indeflator used in the procedure was a non boston scientific device.The inflation pressure was at 12/14 max.It was noted that there was an issue with the balloon, although there did not appear to any under expansion when the nc balloon was used.No patient complications were reported in relation to this event.

Manufacturer Narrative

Device evaluated by mfr: a 12 x 3.00mm promus elite stent delivery system was returned for analysis.The stent was not returned as it was deployed inside the patient.The balloon cones were reviewed via scope, and no visible damage was noted.The balloon was returned in a deflated state.A visual and tactile examination of the hypotube found a kink 26.3cm distal to the distal end of the strain relief.Examination of the tip via scope found no damage to the tip.The shaft polymer extrusion including the distal and mid shaft sections were examined via scope and a tactile examination was performed.A fracture was located on the lasercut region, 34.2 cm proximal to the distal tip.The inflation device was verified before and after use.A recommended 0.014inch guidewire was introduced into the device to facilitate the functional testing.An attempt was made to inflate the balloon when a leak was noted at the site of the lasercut fracture and the device could not maintain pressure.The shaft was cut distal to the fracture site and an inflation aid was attached to evaluate the balloon.The balloon inflated to rated burst pressure of 16 atm and deflated under 30 seconds.No damage was noted on the balloon.No other issues were identified during the product analysis.

Event Description

It was reported that a balloon hole, failure to fully inflate, and additional intervention occurred.A 12 x 3.00 promus elite mr stent was advanced to the target lesion, but it was noticed that there was a hole in it and would not fully inflate.However, the stent was deployed and the stent was fully apposed by using a non compliant (nc) balloon.The procedure was completed.No patient complications resulted in relation to this event and the patient was reported to be stable following the procedure.It was further reported that the target lesion was located in the left anterior descending artery (lad).No patient complications were reported in relation to this event.It was further reported that no other device was present in the vessel.The indeflator used in the procedure was a non boston scientific device.The inflation pressure was at 12/14 max.It was noted that there was an issue with the balloon, although there did not appear to any under expansion when the nc balloon was used.No patient complications were reported in relation to this event.

• Brand Name: PROMUS ELITE
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11368647
• MDR Text Key: 233239842
• Report Number: 2134265-2021-02155
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/10/2022
• Device Model Number: 10671
• Device Catalogue Number: 10671
• Device Lot Number: 0025757862
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2021
• Initial Date Manufacturer Received: 02/17/2021
• Initial Date FDA Received: 02/23/2021
• Supplement Dates Manufacturer Received: 03/02/2021; 04/21/2021; 05/19/2021
• Supplement Dates FDA Received: 03/18/2021; 04/22/2021; 05/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention