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

Model Number 10664

Device Problems Device Markings/Labelling Problem (2911); Device-Device Incompatibility (2919); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/01/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: date of event is unknown.Bsc became aware of the event on (b)(6) 2020.Therefore, a date of (b)(6) 2020 was entered to indicate that the event occurred on an unknown day in (b)(6) 2020.Device is a combination product.

Event Description

It was reported that an additional stent was on the delivery system.A 20 x 3.00 promus premier select stent was advanced to the target lesion and deployed.The stent delivery system was removed, but it was noticed that another 20 x 3.00 promus premier select stent was still attached on the balloon.The user reported there were two stents included on one delivery system prior to use.The procedure was completed successfully and no patient complications were reported in relation to this event.

Manufacturer Narrative

B3: date of event: date of event is unknown.Bsc became aware of the event on (b)(6) 2020.Therefore, a date of (b)(6) 2020 was entered to indicate that the event occurred on an unknown day in (b)(6) 2020.Device evaluated by mfr: a stent was returned for analysis without a stent delivery system.The stent appears to have been expanded and damaged.The stent dimensions were measured with an approximate length of 16mm and approximate width of 3 to 4mm.The measurements were approximated as stent was not straight and the stent was damaged.The stent had 14 segments and 8 peaks.There were 2 rows of 4 connectors at one end of the stent (indicating proximal end based on stent design), 2 connectors for remainder of the stent, at the proximal end there were 3 peaks between each connector.Examination of the stent under scope found that it appeared to be coated.The stent size was compared to the distal end of a 7 and an 8fr guide catheter and the stent diameter was larger than the distal ends of the guide catheters demonstrating that the stent could not have been withdrawn into a guide catheter without more severe damage to the stent struts.The stent size was compared the inner diameter specification of the coil packaging hoop.The coil packaging hoop for 20 x 3.00 promus premier select has an inner diameter of 0.175 inches (4.445mm), which is greater than the diameter of the returned stent.

Event Description

It was reported that a stent dislodged and incorrect content on device occurred.A 20 x 3.00 promus premier select stent was advanced to the target lesion and deployed.The stent delivery system was removed, but it was noticed that another 20 x 3.00 promus premier select stent was still attached on the balloon.There were two drug eluting stents attached on one device.It was noted that one stent was deployed, but as the delivery system was removed, another stent was noticed to be present on the delivery system.It was noted that two stents were on one delivery system before advancing inside the patient.The procedure was completed successfully and no patient complications were reported in relation to this event.

• Brand Name: PROMUS PREMIER SELECT
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10254695
• MDR Text Key: 198326839
• Report Number: 2134265-2020-07989
• 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: 09/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2022
• Device Model Number: 10664
• Device Catalogue Number: 10664
• Device Lot Number: 0025029442
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2020
• Initial Date Manufacturer Received: 06/10/2020
• Initial Date FDA Received: 07/09/2020
• Supplement Dates Manufacturer Received: 08/18/2020
• Supplement Dates FDA Received: 09/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1