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

Model Number 9388

Device Problems Device-Device Incompatibility (2919); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/17/2019

Event Type  malfunction  

Manufacturer Narrative

Device is a combination product.(b)(6).

Event Description

It was reported that stent movement on balloon occurred.Vascular access was obtained via the femoral artery.The 40mm in length de novo target lesion was located in the moderately tortuous, 3 - 3.50mm in diameter, proximal right coronary artery.Following pre-dilatations with 80% residual stenosis, a 2.75x24mm promus element plus drug-eluting stent was advanced for treatment, but failed to cross the lesion.It was then noted that the stent slipped over its balloon.The device was removed and the procedure was discontinued.There were no patient complications reported and the patient was stable.

Manufacturer Narrative

Date of event corrected to (b)(6) 2019.Device is a combination product.

Event Description

It was reported that stent movement on balloon occurred.Vascular access was obtained via the femoral artery.The 40mm in length de novo target lesion was located in the moderately tortuous, 3 - 3.50mm in diameter, proximal right coronary artery.Following pre-dilatations with 80% residual stenosis, a 2.75x24mm promus element plus drug-eluting stent was advanced for treatment, but failed to cross the lesion.It was then noted that the stent slipped over its balloon.The device was removed and the procedure was discontinued.There were no patient complications reported and the patient was stable.It was further reported that when the stent did not cross the target lesion it also fused with the proximal stent.The stent remained on the balloon.

Event Description

It was reported that stent movement on balloon occurred.Vascular access was obtained via the femoral artery.The 40mm in length de novo target lesion was located in the moderately tortuous, 3 - 3.50mm in diameter, proximal right coronary artery.Following pre-dilatations with 80% residual stenosis, a 2.75x24mm promus element plus drug-eluting stent was advanced for treatment, but failed to cross the lesion.It was then noted that the stent slipped over its balloon.The device was removed and the procedure was discontinued.There were no patient complications reported and the patient was stable.It was further reported that when the stent did not cross the target lesion it also fused with the proximal stent.The stent remained on the balloon.

Manufacturer Narrative

Device is a combination product.A promus element plus,mr,ous 2.75x24mm stent delivery system (sds) was returned for analysis broken into 2 sections and without a stent.No stent returned.The balloon was reviewed and no damage was noted.The balloon folds were relaxed, indicating the balloon may have been inflated.A visual and tactile examination of the hypotube found multiple hypotube kinks and a break in the hypotube 1mm distal of the distal end of the strain relief.A visual and tactile examination of shaft polymer extrusion revealed no issues.Examination of the tip found no damage to the tip.No other issues were identified during the device analysis.Media was returned for analysis.Balloon pre-dilation is carried out within a previously deployed stent in the rca.There appears to be a severely or totally occluded lesion in the distal rca at the distal end of the previously deployed stent.Balloon pre-dilation is then carried out in the distal rca resulting in some flow improvement into the previously occluded distal rca.A stent is advanced into the rca but the device cannot cross the distal rca lesion, tension evident on the guidewire demonstrated the deice met resistance when attempting to push the device across the lesion.The unexpanded stent is withdrawn successfully back into the guide catheter and out of view.Further balloon pre-dilation is carried out in the distal rca.A stent is advanced into the rca but despite 2 attempts this device cannot cross the distal rca lesion, tension evident on the guidewire demonstrated the device met resistance when attempting to push the device across the lesion.It was not possible to determine if this was the same or a different stent as used in the previous attempt however the stent was the same in appearance and size as the previously seen stent.An attempt is then made to withdraw the stent into the guide catheter.The proximal half of the stent is damaged when the proximal end of the stent comes into contact with the guide catheter and is bunched distally on the balloon, the distal end of the stent appears to be unaffected.The damaged stent is then advanced back into the proximal rca, the proximal half of the stent can be seen as bunched onto the mid-section of the stent.The stent delivery system is then withdrawn.A single marker band could be seen in the guide catheter and the proximal end of the previously deployed stent appeared deformed.In the following series the markerband was no longer seen and no further interventions were carried out.The location of the deformation of the previously deployed stent indicated that it may have been caused by coming into contact with the damaged unexpanded stent.

• Brand Name: PROMUS ELEMENT PLUS
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9282228
• MDR Text Key: 168295560
• Report Number: 2134265-2019-13429
• 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,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 02/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/22/2020
• Device Model Number: 9388
• Device Catalogue Number: 9388
• Device Lot Number: 0022886565
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2020
• Date Manufacturer Received: 02/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 100