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

Catalog Number	1550400-15
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Intimal Dissection (1333)
Date of Event	10/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for analysis.A conclusive cause for the reported device operates differently and the reported intimal dissection cannot be determined.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Review of the complaint history identified no similar incidents from this lot.Intimal dissection is listed in the xience sierra, everolimus eluting coronary stent system, electronic instructions for use as a known patient effect of coronary stenting procedures.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.
Event or Problem Description
It was reported that the procedure was to treat a heavily calcified mid right coronary artery.Pre-dilatation was performed with a non-abbott balloon dilatation catheter and a 4.00x15mm xience sierra stent was implanted at 12 atmopsheres.A coronary artery dissection was noted after implantation.The physician felt that the stent delivery balloon grew too much outside the stent, like an overhang outside the length of the stent on the proximal end of the balloon, resulting in the dissection.Another xience sierra stent was implanted to treat the dissection.There was no adverse patient sequela an no reported clinically significant delay in the procedure.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: 8146751
• Report Number: 2024168-2018-09478
• Device Sequence Number: 1326874
• Product Code: NIQ
• UDI-Device Identifier: 08717648227493
• UDI-Public: 08717648227493
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 12/10/2018

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: 07/16/2019
• Device Catalogue Number: 1550400-15
• Device Lot Number: 8063041
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2018
• Initial Report FDA Received Date: 12/10/2018
• 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: 68 YR