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

Model Number 10676

Device Problem Break (1069)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 08/27/2020

Event Type  Injury  

Manufacturer Narrative

Age at time of event: 18 years or older.

Event Description

It was reported that shaft break occurred.The 80% target lesion was located in the left anterior descending artery (lad).A 2.5mm emerge balloon was advanced to predilate the target lesion.A 32 x 3.00 promus elite stent was advanced to the target lesion and deployed.It was noted that the balloon was inflated to 14 atmospheres.After the stent was implanted, the stent balloon was used to post dilate the stent again.The balloon became caught in the proximal part of the stent.The delivery system was pulled slightly and the shaft was torn.The balloon was retrieved with a snare device.The procedure was completed.It was noted the physician felt the event may have occurred due to inadequate deflation time.There were no patient complications and the patient was fine.

Event Description

It was reported that shaft break occurred.The 80% target lesion was located in the left anterior descending artery (lad).A 2.5mm emerge balloon was advanced to predilate the target lesion.A 32 x 3.00 promus elite stent was advanced to the target lesion and deployed.It was noted that the balloon was inflated to 14 atmospheres.After the stent was implanted, the stent balloon was used to post dilate the stent again.The balloon became caught in the proximal part of the stent.The delivery system was pulled slightly and the shaft was torn.The balloon was retrieved with a snare device.The procedure was completed.It was noted the physician felt the event may have occurred due to inadequate deflation time.There were no patient complications and the patient was fine.

Manufacturer Narrative

Age at time of event: 18 years or older.H6: patient codes - updated from no code available: 3191 to no consequences or impact to patient: 2199.Device evaluated by mfr: a 32 x 3.00mm promus elite stent delivery system (sds) was returned for analysis.The device was returned without the distal inner section, outer polymer extrusion, balloon, stent and distal tip.A visual and tactile examination of the hypotube found multiple kinks.A visual examination of the outer and inner lumen and mid shaft section found the distal inner section and the outer polymer extrusion sections not returned.Stretching and a break was identified at the distal shaft region with located at 120cm distal to the distal end of the strain relief.No other issues were identified during the product analysis.

• 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: 10605956
• MDR Text Key: 209154392
• Report Number: 2134265-2020-12986
• 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,Followup
• Report Date: 11/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/23/2021
• Device Model Number: 10676
• Device Catalogue Number: 10676
• Device Lot Number: 0024531025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2020
• Date Manufacturer Received: 10/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention