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

Catalog Number	1550225-15
Medical Device Problem Codes	Entrapment of Device (1212); Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Vessel Or Plaque, Device Embedded In (1204)
Date of Event	11/26/2018
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.Stents: 3 unknown xience sierra stents, 3.25 x 28 mm xience sierra stent.(b)(4).The additional 3.25 x 28 xience sierra device referenced is being filed under a separate medwatch report.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 xience sierra everolimus eluting coronary stent system (eecss), domestic, instructions for use states: when treating multiple lesions within the same vessel, stent the distal lesion prior to stenting the proximal lesion.Stenting in this order obviates the need to cross the proximal stent during placement of the distal stent, and reduces the chances of damaging or dislodging the proximal stent.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely the stent interacted with the previously deployed stent while attempting to cross/position (against instructions for use) causing the reported failure to advance, device entrapment and subsequent stent dislodgement with the patient effects of device embedded and additional therapy/non-surgical treatment.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 to treat a moderately tortuous right coronary artery.A 3.25 x 28 mm xience sierra stent was implanted along with 3 other unspecified xience sierra stents without any device issues.As a gap was noted between 2 stents, a 2.25 x 15 mm xience sierra stent was advanced to the lesion; however, the stent became caught with the 3.25 x 28 mm sierra stent.It was noted under angiography that the 3.25 x 28 mm sierra stent was not damaged.The 2.25 x 15 mm sierra stent delivery system (sds) was then moved back and forth to remove the stent, and it dislodged.Therefore, an unspecified trek and a 1.5 x 12 mm mini trek balloon catheter were used to crush the stent to the 3.25 x 28 mm stent.Post-dilatation was then performed with a 3.5 x 15 mm nc trek balloon catheter to successfully complete 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: 8184228
• Report Number: 2024168-2018-09919
• Device Sequence Number: 14139568
• Product Code: NIQ
• UDI-Device Identifier: 08717648227011
• UDI-Public: 08717648227011
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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): 12/20/2018

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: 09/12/2019
• Device Catalogue Number: 1550225-15
• Device Lot Number: 8090541
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2018
• Initial Report FDA Received Date: 12/20/2018
• 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: Other; Required Intervention
• Patient Age: 84 YR
• Patient Weight: 78