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

Catalog Number	1125350-12
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Advance (2524); Device Damaged by Another Device (2915); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Vessel Or Plaque, Device Embedded In (1204)
Date of Event	12/07/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history did not indicate a lot specific quality issue.The investigation determined the reported difficulties and treatment appear to be related to circumstances of the procedure as it is likely the device interacted with the previously deployed stent causing the reported failure to advance and subsequently the reported difficulty to remove.Resistance was felt during removal of the device likely due to the reported interaction with the previously deployed stent causing the reported stent dislodgement and damage to the previously implanted stent.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the distal left main (lm) coronary artery with mild calcification and restenosis.Following the deployment of a 4.0 x 12 mm non-abbott stent in the ostium of the lm, a 3.50 x 12mm xience alpine stent delivery system (sds) was advanced; however could not cross into the ostium of the circumflex artery due to interaction with the previously deployed stent.An attempt to withdraw the sds into the guide catheter was made, but the stent of the sds was stuck and dislodged.The dislodged stent was located outside the lm close to the aorta and proximal to the deployed stent.The deployed non-abbott stent was noted to be stretched.An additional non-abbott stent was deployed to secure both the dislodged and deployed stents and treat the target lesion.The patient was reported to be stable with good blood flow.No additional information was provided.

• Brand Name: XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Common Device Name: DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8166605
• Report Number: 2024168-2018-09727
• Device Sequence Number: 2024844
• Product Code: NIQ
• UDI-Device Identifier: 08717648199516
• UDI-Public: 08717648199516
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 12/14/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/04/2021
• Device Catalogue Number: 1125350-12
• Device Lot Number: 8022041
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2018
• Initial Report FDA Received Date: 12/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Weight: 70