MAUDE Adverse Event Report: AV-TEMECULA-CT ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM; BIORESORBABLE DRUG ELUTING SCAFFOLD

Catalog Number 1012463-23

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hematoma (1884)

Event Date 10/27/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The absorb 3.5 x 28 mm scaffold referenced is being filed under a separate manufacturer report number.The absorb device is currently not commercially available in the u.S; however, it is similar to a device sold in the u.S.The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.Based on the case information and related record review, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.

Event Description

It was reported that the procedure was to treat a lesion located in the proximal, mid and distal left anterior descending (lad) artery with heavy calcification.Predilatation was performed and a 2.5x28mm absorb was placed in the distal lad.The placement was successful and uneventful.Then a 3.0x23mm absorb was placed in the mid lad.The placement was successful and uneventful.A 3.5x28mm absorb was advanced to the proximal lad and was placed overlapping the 3.0x23mm absorb with 9 atmospheres, one inflation for 30 seconds.While overlapping there was a hematoma that was seen in the overlapping area.A 3.0x28 xience alpine was then placed in the overlapping area successfully.There was no clinically significant delay in the procedure.The patient was doing fine and was later discharged.No additional information was provided.

• Brand Name: ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM
• Type of Device: BIORESORBABLE DRUG ELUTING SCAFFOLD
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 6130335
• MDR Text Key: 60990630
• Report Number: 2024168-2016-08377
• Device Sequence Number: 1
• Product Code: PNY
• UDI-Device Identifier: 08717648157035
• UDI-Public: (01)08717648157035(17)170418(10)604196A
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P150023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 11/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/18/2017
• Device Catalogue Number: 1012463-23
• Device Lot Number: 604196A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SCAFFOLD: ABSORB (3.5 X 28, 2.5 X 28)
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR
• Patient Weight: 78