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

Model Number 9550

Device Problems Premature Activation (1484); Difficult to Remove (1528); Failure to Advance (2524)

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

Event Date 07/07/2022

Event Type  Injury  

Event Description

It was reported that removal difficulties and premature stent deployment occurred.The patient presented with unstable angina pectoris.The severely stenosed target lesion was located in the left main (lm) and left anterior descending artery (lad).The right radial artery was successfully punctured and left and right coronary angiograms were performed.Angiography results showed a 95% stenosis in the opening of lm, 80% stenosis in the opening of lad, 80-90% diffuse stenosis in the proximal mid-segment, 50% stenosis in the mid-segment, forward blood flow was timi 3, 30-40% stenosis in the middle segment of left circumflex (lcx), forward blood flow was timi 3.Right coronary artery (rca) mid-segment stenosis of 40-50%, forward blood flow was timi 3.The percutaneous coronary intervention (pci) was performed to the lad, because the 3.5 non-bsc guiding catheter was difficult to hook, the physician replaced the catheter with 4.0 non-bsc guiding catheter in the opening of left coronary.The catheter reached the opening of left coronary opening and a runthrough guidewire reached the distal end of the lad.A non-bsc guidewire reached the lcx for distal protection.A 2.5x15mm non-bsc balloon was primed at 10-18 atmospheres (atm) to dilate the proximal end of lad and stenosis lesion in the lm.Then 3.0x26mm non-bsc stent was implanted in the proximal segment of lad with 14 atm dilatation and deployment.A promus premier 3.5 x 20mm stent was then implanted in the lm-lad, but it was difficult to put it in place.The lm lesion was dilated again with the 3.5x15mm non-bsc balloon catheter.The original promus premier stent was still difficult to cross, difficult to withdraw, released in situ, and the stent was partially outside the opening of the left coronary.The original runthrough guidewire was then penetrated through the stent mesh to the distal part of the lad.The stent mesh was expanded with the 2.0x15mm non-bsc stent followed by dilatation of a 2.5x15mm, 3.0x12mm, and 3.5x10mm non-bsc balloon catheters at 14-22atm.A 3.5x15mm non-bsc stent was delivered to the lm-lad with the support of a guidezilla.The device was dilated and deployed at 0.5mm out from the opening of lm at 16-20atm, and then the stent was post-dilated with 4.0x15mm non-bsc balloon at 10-16 atm.Angiography indicated that the stent was fully dilated and the forward blood flow was timi 3.The procedure was completed and radial artery compression was used to stop the bleeding.There were no patient complications reported.

Manufacturer Narrative

Device evaluated by mfr.: promus premier ous mr 20 x 3.50 mm stent delivery system was returned for analysis without the stent.An examination of the crimped stent found that the stent was not returned with the device.A review of the manufacturing stent profile data was performed and the stent outer diameter at the time of manufacture was within max crimped stent profile measurement.The balloon cones were reviewed, and signs of positive pressure applied to the cones were noted as its wings were relaxed and not tightly folded.The distal balloon cone was noted to be bunched distally.Proximal markerband was noted to be shifted proximally from its intended location.A visual and microscopic examination of the bumper tip showed no signs of tip damage.A visual and tactile examination of the hypotube shaft found multiple kinks along the length of the hypotube shaft.A visual and tactile examination of the outer and mid-shaft section found an inner shaft damage 6.4 cm proximal to distal tip as well as shaft polymer extrusion stretching starting at 23.5 cm from tip and continuing for 7 cm.No other issues were identified during the product analysis.

Event Description

It was reported that removal difficulties and premature stent deployment occurred.The patient presented with unstable angina pectoris.The severely stenosed target lesion was located in the left main (lm) and left anterior descending artery (lad).The right radial artery was successfully punctured and left and right coronary angiograms were performed.Angiography results showed a 95% stenosis in the opening of lm, 80% stenosis in the opening of lad, 80-90% diffuse stenosis in the proximal mid-segment, 50% stenosis in the mid-segment, forward blood flow was timi 3, 30-40% stenosis in the middle segment of left circumflex (lcx), forward blood flow was timi 3.Right coronary artery (rca) mid-segment stenosis of 40-50%, forward blood flow was timi 3.The percutaneous coronary intervention (pci) was performed to the lad, because the 3.5 non-bsc guiding catheter was difficult to hook, the physician replaced the catheter with 4.0 non-bsc guiding catheter in the opening of left coronary.The catheter reached the opening of left coronary opening and a runthrough guidewire reached the distal end of the lad.A non-bsc guidewire reached the lcx for distal protection.A 2.5x15mm non-bsc balloon was primed at 10-18 atmospheres (atm) to dilate the proximal end of lad and stenosis lesion in the lm.Then 3.0x26mm non-bsc stent was implanted in the proximal segment of lad with 14 atm dilatation and deployment.A promus premier 3.5 x 20mm stent was then implanted in the lm-lad, but it was difficult to put it in place.The lm lesion was dilated again with the 3.5x15mm non-bsc balloon catheter.The original promus premier stent was still difficult to cross, difficult to withdraw, released in situ, and the stent was partially outside the opening of the left coronary.The original runthrough guidewire was then penetrated through the stent mesh to the distal part of the lad.The stent mesh was expanded with the 2.0x15mm non-bsc stent followed by dilatation of a 2.5x15mm, 3.0x12mm, and 3.5x10mm non-bsc balloon catheters at 14-22atm.A 3.5x15mm non-bsc stent was delivered to the lm-lad with the support of a guidezilla.The device was dilated and deployed at 0.5mm out from the opening of lm at 16-20atm, and then the stent was post-dilated with 4.0x15mm non-bsc balloon at 10-16 atm.Angiography indicated that the stent was fully dilated and the forward blood flow was timi 3.The procedure was completed and radial artery compression was used to stop the bleeding.There were no patient complications reported.It was further reported that the stent was dislodged and the balloon was difficult to pull out as it could not be fully retracted.

• Brand Name: PROMUS PREMIER
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15107910
• MDR Text Key: 296652773
• Report Number: 2124215-2022-26684
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/21/2022

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: 11/15/2023
• Device Model Number: 9550
• Device Catalogue Number: 9550
• Device Lot Number: 0028425497
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/13/2022
• Initial Date FDA Received: 07/26/2022
• Supplement Dates Manufacturer Received: 09/07/2022
• Supplement Dates FDA Received: 09/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male