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

Catalog Number	1550400-23
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Difficult to Advance (2920); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Evaluation summary: visual, dimensional and functional inspections were performed on the returned device.The resistance with the guiding catheter was not confirmed.The reported damage tip was confirmed.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 revealed no other similar incidents.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.Based on the information reviewed, 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 an 80% stenosed, non tortuous, and moderately calcified lesion in the mid right coronary artery.An attempt to advance a 4.0x23mm xience alpine stent delivery system (sds) and buddy guide wire through a 7f guide catheter was made; however, the sds met resistance with the guide catheter and the the tip of the sds was mangled.The sds did not exit the guide catheter.Everything was pulled out as a unit and the procedure was successfully completed with a new 4.0x23mm xience alpine stent.There were no adverse patient effects and no clinically significant delay in the procedure.The return device analysis identified the distal tip had two splits going proximally for a length of 2mm.No additional information was provided.

• Brand Name: XIENCE SIERRA 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: 8062097
• Report Number: 2024168-2018-08717
• Device Sequence Number: 1437533
• Product Code: NIQ
• UDI-Device Identifier: 08717648227516
• UDI-Public: 08717648227516
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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): 11/12/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/02/2019
• Device Catalogue Number: 1550400-23
• Device Lot Number: 8082741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2018
• Initial Report FDA Received Date: 11/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 84 YR
• Patient Weight: 83