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

Catalog Number 1070300-48

Device Problems Stretched (1601); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/03/2019

Event Type  Injury  

Manufacturer Narrative

Exemption number e2019001.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 identified no similar incidents from this lot.The investigation was unable to determine a conclusive cause for the reported material deformation; however, factors that could contribute to material deformation include, but are not limited to, interaction with accessory devices, interaction with patient anatomical morphology, patient disease state and product damage during handling by user.The reported additional therapy/non-surgical treatment appears to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.The xience xpedition 48 is currently not commercially available in the u.S.; however, it is similar to a device sold in the u.S.

Event Description

It was reported that the procedure was performed to treat a moderately tortuous de novo left anterior descending artery that was 80-90% stenosed.The lesion was pre-dilated with a non-abbott 3.0x15mm balloon at 14 atmospheres (atm) and with a non-abbott 3.0x15mm balloon at 14-24atm.A 3.0x48mm xience xpedition stent was deployed at 10atm.Post dilatation was done with a non-abbott 2.75x10mm balloon at 10-20atm and the proximal segment with a non-abbott 3.0x15mm balloon for 14-24mm.The stent was then noted to be stretched 3-4mm, which was further post-dilated with a non-abbott 3.25x15mm balloon at 18-28atm.There was no adverse patient sequela reported.No additional information was provided.

Manufacturer Narrative

Cine images were reviewed by an abbott vascular clinical specialist; however, they were unable to determine, visually, if there was elongation of the stent.There is no indication of a product quality issue with respect to manufacture, design or labeling.H6: device code 2976-material deformation was changed to 1601-stretched.

• Brand Name: XIENCE XPEDITION
• Type of Device: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9581282
• MDR Text Key: 176397362
• Report Number: 2024168-2020-00596
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 02/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/19/2022
• Device Catalogue Number: 1070300-48
• Device Lot Number: 9051041
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BALLOON CATHETER: ACROSS HP 3.0X15; BALLOON CATHETER: APOLLO 2.75X10 MM
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR