MAUDE Adverse Event Report: AV-TEMECULA-CT XIENCE XPEDITION 48 EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT SYSTEM

Catalog Number 1070300-48

Device Problems Deflation Problem (1149); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017)

Patient Problems Non specific EKG/ECG Changes (1817); Hemorrhage/Bleeding (1888)

Event Date 05/07/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.Concomitant medical products: guide wire: fielder fc, guide catheter: medtronic launcher ebu 1.5, the device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat a moderately calcified de novo proximal left anterior descending artery.A 3.0x48mm xience xpedition stent was implanted at the lesion but the balloon was unable to be deflated.The indeflator was changed three times in attempts to deflate the balloon holding negative for 3-5 seconds but was unsuccessful.The patient began experiencing st-transient elevation.Finally the delivery system was forcibly pulled out with the introducer sheath as a single unit and the patient began to bleed out more than usual at the access site due to longer procedure time.The procedure was aborted and the patient remained hospitalized and was discharged after 2 days.There was no adverse patient sequela reported.No additional information was provided.

Manufacturer Narrative

Internal file number - (b)(4).Correction: lot number changed from 8110640 to 8110641 correction: device evaluated by mfr: device status changed from yes to no.Device code 2017: failure to follow instructions, contrast incorrect.The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no similar incidents from this lot.The investigation determined the reported deflation issue and difficulty to remove appears to be related to the use error.It was reported that resistance was felt during retraction of the device and force was applied.It should be noted that the xience xpedition, everolimus eluting coronary stent system (eecss), instructions for use (ifu)states: applying excessive force to the delivery system can potentially result in loss or damage to the stent and/or delivery system components.It is unknown if the ifu deviation contributed to the reported event.In addition, it was reported that the contrast mix used for the procedure was 1 in 3.It should be noted that the xience xpedition,(eecss), ifu states: mixture should be 60% contrast diluted 1:1 with normal saline.It is unknown if the ifu deviation contributed to the reported event.Furthermore, it was reported that negative pressure was held for 3-5 seconds in order to deflate the balloon of the 3.00 x 48 mm xience xpedition stent delivery system; however, the balloon completely failed to deflate.It should be noted that the xience xpedition,(eecss), ifu states: deflate the balloon by pulling negative on the inflation device for 30 seconds.Confirm complete balloon deflation before attempting to move the delivery system.In this case, it is likely the ifu deviation contributed to the reported deflation issue and difficulty to remove.There was no report of any damage noted to the stent delivery system (sds) during inspection or preparation of the device, which suggests that a product quality issue did not contribute to the reported complaint.The reported patient effect of hemorrhage is listed in the xience xpedition, everolimus(eecss), ifu as a known patient effect of coronary stenting procedures.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.A cine was received and reviewed by an abbott vascular clinical specialist.The reviewer concluded that following successful deployment of a 3.0 x 48 xience xpedition, sds balloon failed to deflate completely and was successfully withdrawn from the deployed stent, but was unable to be pulled back into the guide catheter.The stent appears fully deployed in final angiogram.

• Brand Name: XIENCE XPEDITION 48 EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Type of Device: DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8642444
• MDR Text Key: 146209959
• Report Number: 2024168-2019-04106
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/31/2019

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: 11/12/2021
• Device Catalogue Number: 1070300-48
• Device Lot Number: 8110641
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/07/2019
• Initial Date FDA Received: 05/24/2019
• Supplement Dates Manufacturer Received: 07/17/2019
• Supplement Dates FDA Received: 07/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE H10 FOR CONCOMITANT MEDICAL DEVICES
• Patient Outcome(s): Hospitalization