MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

Model Number	1550300-38
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The additional two devices referenced are being filed under separate medwatch report numbers.The device was not returned for evaluation.A review of the lot history record and complaint history of the reported lot could not be conducted because the lot number was not provided.The investigation was unable to determine a conclusive cause for the reported patient-device incompatibility (wall apposition); however, the subsequent treatment appears to be related to the operational context of the procedure.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 heavily calcified circumflex artery.Two xience sierra stent delivery systems (sds) (2.25x38 and 3.0x38mm) were implanted without issue; however, the physician did not like the apposition of where both stents over lapped in the middle.Therefore, the 3.50x18mm xience sierra sds was advanced with no issue, but the balloon ruptured at 2 atmospheres.There was difficulty removing the sds due to the anatomy and the stent became dislodged.A 3.5x15mm non-compliant balloon was advanced and used to treat the malposition.Then an unspecified trek balloon was used to bring the dislodged stent back into the unspecified guide catheter and remove all of the devices as one unit.Once the device was removed it was noted the stent was not in the guide catheter and remained stuck at the right groin.The patient was sent to surgery and a cut down was performed to successfully remove the stent.There was no adverse patient sequela and no clinically significant delay reported.No additional information was provided.

• Brand Name: XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Common Device Name: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 12640035
• Report Number: 2024168-2021-09262
• Device Sequence Number: 11072727
• Product Code: NIQ
• UDI-Device Identifier: 08717648227301
• UDI-Public: 08717648227301
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/15/2021

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 Model Number: 1550300-38
• Device Catalogue Number: 1550300-38
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/23/2021
• Initial Report FDA Received Date: 10/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 2.25X38MM XIENCE SIERRA
• Outcome Attributed to Adverse Event: Required Intervention